FDA Registration
Active
🇺🇸 United States
Isomedix Operations Inc
Reg #: 3009888344
·
FEI: 3009888344
·
Expires 2026
Products
289
Proprietary Names
145
Establishment Types
2
Classifications
289
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Registration Details
- Registration Name
- Isomedix Operations Inc
- Registration Number
- 3009888344
- FEI Number
- 3009888344
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1441 Don Haskins Dr
- City
- El Paso
- State
- TX
- ZIP
- 79936
- Country
- US
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Percutaneous Introducer Kit | PXB | Class 2 | General Hospital | No | 2020-03-20 |
| Chest Drainage Kit | PAD | Class 2 | General Hospital | No | 2020-03-20 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2012-12-27 |
| Dilator, Rectal | FFP | Class 1 | Gastroenterology, Urology | No | 2012-12-27 |
| Blood Specimen Collection Kit (Excludes Hiv Testing) | OFZ | Class 1 | Anesthesiology | No | 2013-01-28 |
| Pelviscopy Kit | PYD | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Disposable Joint Aspiration/Injection Kit | PPP | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2022-04-22 |
| Central Venous Blood Pressure Kit | OFE | Class 2 | Cardiovascular | No | 2013-01-28 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2025-08-27 |
| Cholecystectomy Kit | PXS | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Gastro-Urology Biopsy Kit | PRV | Class 2 | Gastroenterology, Urology | No | 2019-12-21 |
| Staple Removal Kit | PYE | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2025-08-27 |
| Urine Transport Kit (Excludes Hiv Testing) | OHZ | Class 1 | Pathology | No | 2013-01-28 |
| Tracheostomy Cleaning Tray | OGV | Class 2 | Anesthesiology | No | 2013-01-28 |
| Brachial Plexus Anesthesia Kit | OGA | Class 2 | Anesthesiology | No | 2013-01-28 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2012-10-31 |
| Surgical Eye Tray | PZG | Class 1 | Ophthalmic | No | 2020-03-20 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2025-08-27 |
| Regional Anesthesia Kit | OFV | Class 2 | Anesthesiology | No | 2013-01-28 |
| Arthrogram Tray | OII | Class 2 | Radiology | No | 2013-01-28 |
| Ulcer Wound Tray | PYJ | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2012-12-27 |
| Laparascopic Sphincterotomy Kit | PXZ | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Paracentesis Tray | PYC | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Parenteral Administration Kit | POR | Class 2 | General Hospital | No | 2020-03-20 |
| Emergency Response Safety Kit | OKI | Class 2 | General, Plastic Surgery | No | 2013-01-28 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2013-01-28 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2013-01-28 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Endothelial Cell Harvesting Kit | MFY | Class 2 | Cardiovascular | No | 2013-01-28 |
| Catheter, Recording, Electrode, Reprocessed | NLH | Class 2 | Cardiovascular | No | 2013-01-29 |
| Blood Administration Kit | PWO | Class 2 | General Hospital | No | 2020-03-20 |
| Surgical Retractor Kit | PYH | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures | PPR | Class 2 | Orthopedic | No | 2020-03-20 |
| Tourniquet Kit | OJS | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Catheter, Hemodialysis, Triple Lumen, Non-Implanted | NIE | Class 2 | Gastroenterology, Urology | No | 2025-08-27 |
| Gastrointestinal Tube Kit | PRW | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Oxygen Administration Kit | OGL | Class 2 | Anesthesiology | No | 2013-01-28 |
| Labor And Delivery Kit | MLS | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Decontamination Kit | MAC | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Phlebotomy Blood Collection Kit | OFM | Class 2 | Cardiovascular | No | 2013-01-28 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2012-11-14 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2018-01-25 |
| Suture Removal Kit | MCZ | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2025-08-27 |
| Dressing Change Tray | OXQ | Class 1 | General Hospital | No | 2013-01-28 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2012-11-08 |
| Humidifier Nebulizer Kit | OGG | Class 2 | Anesthesiology | No | 2013-01-28 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2012-11-14 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2012-10-31 |
| Transtibial Anterior Cruciate Ligament Kit | PPQ | Class 2 | Orthopedic | No | 2020-03-20 |
| Catheter, Subclavian | LFJ | Class 2 | Gastroenterology, Urology | No | 2025-08-27 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2012-10-31 |
| Culdocentesis Kit | OHF | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Trocar Kit | OKX | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Ostomy Care Kit | PQE | Class 1 | Gastroenterology, Urology | No | 2020-03-20 |
| Spinal Epidural Anesthesia Kit | OFT | Class 2 | Anesthesiology | No | 2013-01-28 |
| Obstetrical Anesthesia Kit | PVU | Class 2 | Obstetrics/Gynecology | No | 2020-03-20 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2025-08-27 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2025-08-27 |
| Blood Alcohol Kit (Excludes Hiv Testing) | OIC | Class 2 | Clinical Toxicology | No | 2013-01-28 |
| Admission Kit (Patient Utensil) | PWM | Class 1 | General Hospital | No | 2020-03-20 |
| Neurological Test Kit | PVP | Class 1 | Neurology | No | 2020-03-20 |
| Cardiopulmonary Bypass Catheter Kit | OEU | Class 2 | Cardiovascular | No | 2013-01-28 |
| Fixture Mount Kit | NYE | Class 1 | Dental | No | 2013-01-28 |
| Radiology-Diagnostic Kit | OIP | Class 2 | Radiology | No | 2013-01-28 |
| Blood Transfusion Kit | POQ | Class 2 | General Hospital | No | 2020-03-20 |
| Male External Catheterization Kit (Excludes Hiv Testing) | PPC | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Lumbar Drainage Catheter Kit | PVO | Class 2 | Neurology | No | 2020-03-20 |
| Single Use Instrument Tray | OJV | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Forensic Evidence Sexual Assault Kit | OHE | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2025-09-17 |
| Dental Hygiene Kit | NXZ | Class 1 | Dental | No | 2013-01-28 |
| Filter, Intravascular, Cardiovascular | DTK | Class 2 | Cardiovascular | No | 2012-11-14 |
| Urinary Drainage Collection Kit | PPG | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2025-08-27 |
| Central Venous Catheter Tray | OFF | Class 2 | Cardiovascular | No | 2013-01-28 |
| Port Introducer Kit | OKE | Class 2 | General Hospital | No | 2013-01-28 |
| Suture Kit | OVN | Class 2 | General, Plastic Surgery | No | 2013-01-28 |
| Wound Drainage Kit | PYL | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| General Purpose Dental Tray | OFX | Class 1 | Dental | No | 2013-01-28 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Tracheotomy Care Kit | NXA | Class 2 | Anesthesiology | No | 2013-01-28 |
| Percutaneous Atrial Catheter Kit | OFK | Class 2 | Cardiovascular | No | 2013-01-28 |
| Hemodialysis Tray (Not A Start/Stop Kit) | PPI | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Midline Catheter | PND | Class 2 | General Hospital | No | 2025-08-27 |
| Biopsy Needle Guide Kit | OIJ | Class 2 | Radiology | No | 2013-01-28 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2025-08-27 |
| Cricothyrotomy Kit | OGP | Class 2 | Anesthesiology | No | 2013-01-28 |
| General Purpose Instrument Tray | PXV | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Emergency Obstetrical Kit | OKU | Class 1 | Obstetrics/Gynecology | No | 2013-01-28 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2025-08-27 |
| Nerve Block Tray | OGJ | Class 2 | Anesthesiology | No | 2013-01-28 |
| Airway Suction Kit | OFO | Class 1 | Anesthesiology | No | 2013-01-28 |
| Breast Pump Kit | OHH | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| D And C Tray | PKF | Class N | Unknown | No | 2020-03-20 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-08-27 |
| Incision Tray | PXX | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Snake Bite Suction Kit | KYP | Class 1 | General Hospital | No | 2012-12-27 |
| Catheter, Cholangiography | GBZ | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Ear, Nose, And Throat Surgical Tray | OGR | Class 1 | Ear, Nose, Throat | No | 2013-01-28 |
| Endoscope Introducer Kit | NWU | Class 2 | Gastroenterology, Urology | No | 2013-01-28 |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | Class 2 | Cardiovascular | No | 2021-08-13 |
| Catheter, Intracardiac Mapping, High-Density, Reprocessed | NLG | Class 2 | Cardiovascular | No | 2021-08-13 |
| Thermometer, Clinical Mercury | FLK | Class 2 | General Hospital | No | 2012-12-27 |
| Pudendal Anesthesia Kit | PVW | Class 2 | Obstetrics/Gynecology | No | 2020-03-20 |
| Custom Anesthesia Tray | OGD | Class 2 | Anesthesiology | No | 2013-01-28 |
| Replacement Gastrostomy Feeding Catheter Tray | PSK | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Catheter Introducer Kit | OFC | Class 2 | Cardiovascular | No | 2013-01-28 |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | Class 2 | Cardiovascular | No | 2019-10-17 |
| Burn Dressing Tray | PXQ | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2003-05-01 |
| Herniorraphy Kit | PXW | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Wound Dressing Kit | MCY | Class 2 | General Hospital | No | 2013-01-28 |
| Ct Biopsy Tray | OFG | Class 2 | Cardiovascular | No | 2013-01-28 |
| Restorative Instrument And Component Tray | OFW | Class 2 | Dental | No | 2013-01-28 |
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2012-10-26 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2012-11-08 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2025-08-27 |
| Sterile Puncture Tray | PYF | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Pap Smear Kit | OHL | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Tube, Feeding | FPD | Class 2 | Gastroenterology, Urology | No | 2022-04-22 |
| Myringotomy Procedure Kit | OGS | Class 2 | Ear, Nose, Throat | No | 2013-01-28 |
| Irrigation Kit (Wounds) | PXY | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Endoscopic Ventricular Catheter Placement Kit | PVM | Class 2 | Neurology | No | 2020-03-20 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2013-01-28 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2013-01-28 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-04-20 |
| Pelvic Exam Kit | MLT | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Dialysis Administration Kit | PEV | Class 2 | Gastroenterology, Urology | No | 2018-09-24 |
| Catheter Guide Wire Kit | OFB | Class 2 | Cardiovascular | No | 2013-01-28 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2012-11-07 |
| Suction Catheter Kit | PYG | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Bone Marrow Collection/Transfusion Kit | LWE | Class 2 | Unknown | No | 2013-01-28 |
| Cytology Kit | OKY | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Continuous Brachial Plexus Block Tray | OGC | Class 2 | Anesthesiology | No | 2013-01-28 |
| Percutaneous Endoscopic Gastrostomy Kit | PSG | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Laser Blood Flow Kit | OFI | Class 2 | Cardiovascular | No | 2013-01-28 |
| Feeding Tube Kit | PRR | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Body Fluids Barrier Kit | OKH | Class 2 | General, Plastic Surgery | No | 2013-01-28 |
| Device, Biopsy, Endomyocardial | DWZ | Class 2 | Cardiovascular | No | 2017-11-13 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Pierced Ear/Entry Cleaning Tray | OGU | Class 1 | Ear, Nose, Throat | No | 2013-01-28 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2022-04-23 |
| Venous Ulcer Kit | PYK | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Gastrostomy Jejunostomy Feeding Tube Kit | PRY | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Mid-Stream Collection Kit | PWZ | Class 1 | General Hospital | No | 2020-03-20 |
| Fetal Blood Sampling Kit (Excludes Hiv Testing) | PVS | Class 2 | Obstetrics/Gynecology | No | 2020-03-20 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2013-01-28 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2025-08-27 |
| Foley Catheter Kit (Excludes Hiv Testing) | PPB | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Laparoscopic Cholecystectomy Kit | PKE | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Clean-Up Kit | PWU | Class 1 | General Hospital | No | 2020-03-20 |
| Epidural Anesthesia Kit | OGE | Class 2 | Anesthesiology | No | 2013-01-28 |
| Seminal Fluid Collection Kit | OKW | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Oral Surgery Tray | PWL | Class 1 | Dental | No | 2020-03-20 |
| Gingival Retraction Kit | NYF | Class 1 | Dental | No | 2013-01-28 |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2020-03-20 |
| Endometrial Sampling Kit | OKZ | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Gynecological Laparoscopic Kit | OHD | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Breast Biopsy / Localization Tray | PXP | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Basic Set-Up Tray | PXN | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Nasogastric Feed Tube Kit | PSB | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Plaque Disclosing Kit | NYH | Class 2 | Dental | No | 2013-01-28 |
| Tissue Processing Kit | PFU | Class N | Unknown | No | 2020-03-20 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | Class 2 | Gastroenterology, Urology | No | 2012-10-31 |
| Multi-Lumen Hemodialysis Catheterization Kit | PPO | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2012-12-27 |
| Body Fluid Clean Up Kit | OKG | Class 2 | General, Plastic Surgery | No | 2013-01-28 |
| Bone Marrow Biopsy Tray | PXO | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Dental Prophylaxis Kit | NYC | Class 1 | Dental | No | 2013-01-28 |
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2013-01-28 |
| Laparoscopy Kit | FDE | Class 2 | Gastroenterology, Urology | No | 2013-01-28 |
| Single Needle With Uni-Directional Pump Kit | PPH | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Perineal Irrigation Kit | PSI | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Urinary Irrigation Kit | PPF | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Glossopharyngeal Anesthesia Kit | OGF | Class 2 | Anesthesiology | No | 2013-01-28 |
| Tube, Gastro-Enterostomy | KGC | Class 2 | Gastroenterology, Urology | No | 2012-10-31 |
| Personal Protection Kit | PXC | Class 1 | General Hospital | No | 2020-03-20 |
| Gastric Irrigation And Aspiration Kit | PRT | Class 2 | Gastroenterology, Urology | No | 2019-12-28 |
| Universal Drainage Tray | PPD | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Endodontic Kit | NYD | Class 2 | Dental | No | 2013-01-28 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2012-12-27 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2001-08-06 |
| Percutaneous Sheath Introducer Kit | OFL | Class 2 | Cardiovascular | No | 2013-01-28 |
| Skin Prep Tray | OJU | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Tracheobronchial Suction Catheter Kit | OFR | Class 1 | Anesthesiology | No | 2018-09-24 |
| Digital Angiography Tray | OFH | Class 2 | Cardiovascular | No | 2013-01-28 |
| Laceration Tray | PKD | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Angioscopic Valvulotome Kit | OER | Class 2 | Cardiovascular | No | 2013-01-28 |
| Peritoneal Dialysis Tubing Kit | PPK | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Electrosurgical Electrode Kit | NWI | Class 2 | Gastroenterology, Urology | No | 2013-01-28 |
| Cardioplegia Solution Administration Kit | OET | Class 2 | Cardiovascular | No | 2013-01-28 |
| Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | SAF | Class 2 | Clinical Chemistry | No | 2025-12-15 |
| Orthopedic Tray | OJH | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Anesthesia Kit | OFQ | Class 2 | Anesthesiology | No | 2013-01-28 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Tracheostomy Kit | OGW | Class 2 | Anesthesiology | No | 2013-01-28 |
| Obstetrical Vacuum Delivery Kit | OHC | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Vaginal Examination Tray | PVX | Class 2 | Obstetrics/Gynecology | No | 2020-03-20 |
| Vomitus Clean-Up Kit | PXM | Class 1 | General Hospital | No | 2020-03-20 |
| Fluid Drainage Tray | PXU | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Dental Implant Surgical Tray | OFY | Class 1 | Dental | No | 2013-01-28 |
| Nasal Endotracheal Tube Holder Kit | OGI | Class 1 | Anesthesiology | No | 2013-01-28 |
| Lapping Tool Kit | NYG | Class 1 | Dental | No | 2013-01-28 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2012-10-31 |
| Denture Repair Kit | EBO | Class 2 | Dental | No | 2013-01-28 |
| Body Fluid Disposal Kit | OKF | Class 2 | General, Plastic Surgery | No | 2013-01-28 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2012-12-28 |
| Endoscopic Shunt Placement Kit | PVL | Class 2 | Neurology | No | 2020-03-20 |
| Thoracentesis Tray | PXI | Class 2 | General Hospital | No | 2020-03-20 |
| Cesarean Section Tray | OHM | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2013-01-28 |
| Vasovasostomy Set | PVY | Class 1 | Gastroenterology, Urology | No | 2020-03-20 |
| Tracheostomy And Nasal Suctioning Kit | LRQ | Class 1 | Unknown | No | 2013-01-28 |
| Cardiovascular Catheter Sheath Introducer Kit | OEX | Class 2 | Cardiovascular | No | 2013-01-28 |
| Endoscopic Cytology Brush | FDX | Class 2 | Gastroenterology, Urology | No | 2012-10-31 |
| Nasogastric-Gastrojejunal Kit | PSC | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Winged Intravenous Catheterization Kit | OFN | Class 2 | Cardiovascular | No | 2013-01-28 |
| Maternity Kit | PVT | Class 1 | Obstetrics/Gynecology | No | 2020-03-20 |
| Prep Kit | PXD | Class 1 | General Hospital | No | 2020-03-20 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2025-08-27 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2012-10-31 |
| Reprocessed Bronchoscope | QNW | Class 2 | Ear, Nose, Throat | No | 2024-01-17 |
| Single Needle (Co-Axial Flow) Dialysis Kit | PPL | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Tracheal Suction Set | OFS | Class 1 | Anesthesiology | No | 2013-01-28 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2012-12-27 |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | Class 1 | Pathology | No | 2013-01-28 |
| Kidney Perfusion Kit | PIN | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Tray, Start/Stop (Including Contents), Dialysis | FKG | Class 1 | Gastroenterology, Urology | No | 2012-12-27 |
| Umbilical Catheter Insertion Tray | PXJ | Class 2 | General Hospital | No | 2020-03-20 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2013-01-28 |
| Balloon Gastrostomy Tube Kit | PRP | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Laparoscopic Gastrostomy Kit | PSD | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Sitz Bath Kit | PXF | Class 1 | General Hospital | No | 2020-03-20 |
| Cardiovascular Surgical Instruments Tray | OFA | Class 1 | Cardiovascular | No | 2013-01-28 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2025-08-14 |
| Spill Kit | PXG | Class 1 | General Hospital | No | 2020-03-20 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Endoscopic Cholangiogram Kit | NWT | Class 2 | Gastroenterology, Urology | No | 2013-01-28 |
| Central Venous Catheter Dressing Change Kit | PEZ | Class 2 | General Hospital | No | 2020-03-20 |
| Rectal Dilator Kit | PSJ | Class 1 | Gastroenterology, Urology | No | 2020-03-20 |
| Aspiration Tray | OJT | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Orotracheal Intubation Guide Kit | OGK | Class 2 | Anesthesiology | No | 2013-01-28 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2012-11-14 |
| Intravenous Extension Tubing Set | OJA | Class 2 | General Hospital | No | 2018-09-24 |
| Catheter Care Tray | OHR | Class 2 | Gastroenterology, Urology | No | 2013-01-28 |
| Lead Introducer Kit | OFJ | Class 2 | Cardiovascular | No | 2013-01-28 |
| Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | KDH | Class 2 | Gastroenterology, Urology | No | 2022-04-23 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2018-04-20 |
| Radiographic Contrast Tray | OIO | Class 2 | Radiology | No | 2013-01-28 |
| Biopsy Needle Kit | POZ | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Hysterectomy Kit | OJF | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Intracranial Pressure & Temperature Monitoring Kit | PSP | Class 2 | Neurology | No | 2020-03-20 |
| Laryngoscope Kit | OGH | Class 1 | Anesthesiology | No | 2013-01-28 |
| Peritoneal Dialysis Administration Kit | PPJ | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse | PWI | Class 2 | Obstetrics/Gynecology | No | 2020-03-20 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2012-12-27 |
| Arterial Blood Sampling Kit | CBT | Class 1 | Anesthesiology | No | 2013-01-28 |
| Cardiac Catheterization Kit | OES | Class 2 | Cardiovascular | No | 2013-01-28 |
| Cardiopulmonary Resuscitation Aid Kit | OEV | Class 2 | Anesthesiology | No | 2013-01-28 |
| Obstetrical Kit | OKV | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Neurological Tray | OJG | Class 1 | Neurology | No | 2013-01-28 |
| Vacuum Powered Body Fluid Collection Kit | OJR | Class 2 | General, Plastic Surgery | No | 2013-01-28 |
| Prostate Seeding Kit | OIN | Class 2 | Radiology | No | 2013-01-28 |
| Lumbar Puncture Tray (Adult & Pediatric) | PWY | Class 2 | General Hospital | No | 2020-03-20 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Vascular Access Port Kit | PXK | Class 2 | General Hospital | No | 2020-03-20 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2012-12-27 |
| Oral Irrigation Kit | OGT | Class 1 | Dental | No | 2013-01-28 |
| Shave Prep Kit | OJW | Class 2 | General, Plastic Surgery | No | 2013-01-28 |
| Suprapubic Cystostomy Catheter Kit | NWP | Class 2 | Gastroenterology, Urology | No | 2018-09-24 |
| Ear Irrigation Kit | OGQ | Class 1 | General Hospital | No | 2013-01-28 |
| Sampler, Amniotic Fluid (Amniocentesis Tray) | HIO | Class 1 | Obstetrics/Gynecology | No | 2012-12-27 |
| Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing) | OIA | Class 1 | Pathology | No | 2013-01-28 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2022-10-20 |
| Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) | OID | Class 1 | Microbiology | No | 2013-01-28 |
| Spinal Anesthesia Kit | OFU | Class 2 | Anesthesiology | No | 2013-01-28 |
| Circumcision Tray | OHG | Class 2 | Obstetrics/Gynecology | No | 2013-01-28 |
| Esophageal Dilator Kit | PRQ | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Bladder Irrigation Kit | PPA | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Burn Kit Without Drug | OJJ | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Gastric Lavage Kit (Adult Or Pediatric Use) | PRU | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Discography Kit | OIL | Class 2 | Radiology | No | 2013-01-28 |
| Caudal Anesthesia Kit | OGB | Class 2 | Anesthesiology | No | 2013-01-28 |
| Laparoscopic Jejunostomy Kit | PSA | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
Proprietary Names
Teleflex (EP2) - Midline Catheter
Teleflex (EP2) - Arrow Seldinger Arterial Catherization Device
Teleflex (EP2) - PICC
Avanos2508 (EP1,EP2) - Single Shot Tray Products or Continuous Tray Products
Teleflex (EP2) - Large Bore Multi-Lumen CVC
Zenflow34605 (TM) - Zenflow Spring Implant Retrieval Device
Teleflex (EP2) - Multi-Lumen Acute Hemodialysis Catheter
Solventum14471 (SP) - 3M Steri-Drape
Teleflex (EP2) - Arrow Epidural Anesthesia Kit
Teleflex (EP2) - Flextip Plus Closed Tip Epidural Catheter
Teleflex (EP2) - FLEXTIP PLUS CLOSED TIP EPIDUR
Teleflex (EP2) - Single Lumen CVC
Teleflex (EP2) - Arrow MAC Two-Lumen Central Venous Access Kit
Teleflex (EP2) - Arrow Large Bore Dual Lumen Hemodialysis Kit
Teleflex (EP2) - Arrow Jugular Puncture Kit
Teleflex (EP2) - 19 GA PLASTIC REINFORCED EPIDU
Teleflex (EP2) - Pressure Injectable PICC
Teleflex (EP2) - Arterial Access Kit
Teleflex (EP2) - Arrow Endurance Extended Dwell Peripheral Catheter System
Avanos2508 (EP1,EP2) - Kimberly-Clark
Teleflex (EP2) - Arrow Pressure Inectable Peripherally Inserted Central Catheter
Teleflex (EP2) - Arterial Catheter
Teleflex (EP2) - Arrow Radial Artery
Teleflex (EP2) - StimuCath Contiuous Peripheral Nerve Block Kit
Teleflex (EP2) - Arrow Continuous Nerve Block Kit
Teleflex (EP2) - Arrow Pressure Injectable Central Venous Catheterization Kit
Teleflex (EP2) - Arrow Pressure Injectable Central Venous Catheter
Teleflex (EP2) - Arrow Pressure Injectable Midline Catheter
Teleflex (EP2) - Introducer Needle
Smith&Nephew3754 (NR) - (6) Passing Pins, Drill Tip, 2.7mm x 381mm
Smith&Nephew3754 (NR) - 4.5 Incisor
S&N3754 (NR) - Drill, 1.6mm and Guide, Dynomite 2
Smith&Nephew3754 (NR) - Drill, 2.6mm and Guide, Raptormite 3
S&N3754 (NR) - Drill, 3.2mm and Guide, Raptormite 3.7
Smith&Nephew3754 (NR) - Drill, 1.8mm and Guide, Spyromite / Minitac2
Wolfmed8101 (MN) - DIAMOND BURR 3MM WL 350MM ROUND
Teleflex (EP2) - ATRAUMATIC STANDARD SPROTTE
Teleflex (EP2) - Arrow Central Venous Catheterization Kit
Ranfac3098 (NR) - ORC-B, ORC-A, LAP-13, ORC-XL11
Ranfac3098 (NR) - Cholangiography Catheter
Teleflex (EP2) - Arrow Quickflash Arterial Catheterization Device
Avanos2508 (EP1,EP2,NT) - MIC PEG TUBE
Avanos2508 (EP1,EP2,NT) - MIC PEG Kit
PFMMedical6614 (TM) - 5.5F x 5cm Micro Introducer Kit (Ref M550540)
PFMMedical6614 (TM) - 5.5F x 7cm Micro Introducer Kit (Ref M550740)
PFMMedical6614 (TM) - 4.5F x 5cm Micro Introducer Kit (Ref M450540)
PFMMedical6614 (TM) - 3.5F x 5cm Micro Introducer Kit (Ref M350540)
PFMMedical6614 (TM) - 6.5F x 7cm Micro Introducer Kit (Ref M650740)
PFMMedical6614 (TM) - 3.5F x 7cm Micro Introducer Kit (Ref M350740)
PFMMedical6614 (TM) - 4.5F x 7cm Micro Introducer Kit (Ref M450740)
PFMMedical6614 (TM) - 6.5F x 5cm Micro Introducer Kit (Ref M650540)
Hollister (SP,LS,LN) - Moderma Flex; New Image; Nova 2; NovaLife 1; NovaLife 1 GX+; NovaLife 2; NovaLife 2 GX+; Pouchkin
Hollister (LN, LS) - Ostomy Skin Barriers
Hollister (SP,LS,LN) - Premier; Restore; Securi-T USA; Suavita; Tandem; Urostomy Drain Tube Adapter
Hollister (LN, LS) - Hollister
Hollister (SP,LS,LN) - Adapt; Center Point Lock; Compact; Conform 2; Dansac; Drainable Pouch Clamp; DuoSoft; Fecal Colle
Hollister (SP,LS,LN) -First Choice; Holligard; Hollister Solo Stoma Cap; Invent; Karaya 5; Moderma Flex; New Image
Teleflex (EP2) - ARROW EPIDURAL CATHETERIZATIO
Teleflex (EP2) - SPROTTE
Teleflex (EP2) - Surgical Drape
Teleflex (EP2) - Radial Artery Catheterization Set with Integral Needle Protection
Protech3048 (TM) - Falcon
Protech3048 (TM) - Awl
Protech3048 (TM) - Lightning
Merit1383 (SN) - ShortStop Temporary Sharps Holder
Merit1383 (TM) - BackStop Plus Closed Waste Basin
Merit1383 (SN) - ShortStop Advantage Temporary Sharps Holder
Merit1383 (NT,SN) - ShortStop Advantage Temporary Sharps Holder
Ranfac3098 (NR) - SS-1529, Hypodermic Needle, S-115
BVI1689 (CH1,EP1) - Retrobulbar
BVI1689 (EP1, CH1) - Peribulbar
Clearside6394 (MN,SP) - SCS Microinjector
Depuy (NR) - CELLECT BONE MARRO; CONFIDENCE SPINAL CEMENT SYSTEM
Ursel11054 (MN) - TRU-CLOSE Suction Drainage System
Teleflex (EP2) - Pneumothorax Kit; Pneumothorax kit w/Sutures
Teleflex (EP2) - Lake Region Guide Wire
TerumoMed3380 (NR) - Mandrel Guidewire Assembly
Teleflex (EP2) - Arrow FlexBlock Continous Peripheral Nerve Block Kits
Avanos2508 (EP1,EP2,NT) - MIC LOW PROFILE GASTROSTOMY TUBE
Avanos2508 (EP1,EP2,NT) - CORFLO* PEG Kit
Avanos2508 (EP1,EP2) - Gastropexy Kit and Dilator
US_Endoscopy4223 (SP) - BioGuard air/water & suction valves-Olympus (3 pc kit)
US_Endoscopy4223 (SP) - BioGuard air/water & suction valves-Olympus (4 pc kit)
Protech3048 (TM) - Vampiro
Avanos2508 (EP1,EP2) - AVANOS* Universal Block Trays
Avanos2508 (EP1,EP2) - Prep Trays
Avanos2508 (EP1,EP2) - Nerve Block Tray
Avanos2508 (EP1,EP2) - Whitacre Needle
Avanos2508 (EP1,EP2) - Single Shot Epidural Trays
Teleflex (EP2) - Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip Catheter
Zimmer (LS) - Creartions SCP Hip Kit
Dexcom2055 (EP2) - Dexcom ONE+ Continuous Glucose Monitoring System
StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK-SOFT TISSUE FIXATION
StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK BONE-TENDON-BONE
BVI1689 (EP1) - CustomEyes
Zimmer (LN,LS) - Toggleloc
Zimmer (LN,LS) - Maxfire
Acuderm1463 (WH,LS) -Acu-Punch Kit
Teleflex (EP2) - Vascular Positioning System (VPS System) Stylet
Avanos2508 (EP1,EP2) - ON-Q* PAIN RELIEF SYSTEM T-BLOC* CONTINUOUS ECHOGENIC NERVE BLOCK WITH NRFit" CONNECTOR
Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Ultrasound Nerve Block Prep Tray
Avanos2508 (EP1,EP2) - anesthesia conduction kit - ON-Q* Pain Relief System T-Bloc Continuous Echogenic Nerve Block Tray
Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Needle/Catheter Set
Avanos2508 (EP1,EP2) - ON-Q* PAIN RELIEF SYSTEM T-BLOC* CONTINUOUS ECHOGENIC STIMULATING NERVE BLOCK TRAY WITH NRFit"
Avanos2508 (EP1,EP2) - ON-Q* PAIN RELIEF SYSTEM T-BLOC* ECHOGENIC STIMULATING NEEDLE/CATHETER SET WITH NRFit" CONNECTOR
Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Continuous Echogenic Stimulating Nerve Block Tray
Avanos2508 (EP1,EP2) - ON-Q* PAIN RELIEF SYSTEM T-BLOC* ULTRASOUND NERVE BLOCK PREP TRAY WITH NRFit" CONNECTOR
Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Echogenic Needle/Catheter Set
Avanos2508 (EP1,EP2) - PERIPHERAL NERVE BLOCK SUPPORT TRAY
Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Echogenic Stimulating Needle/Catheter Set
Avanos2508 (EP1,EP2) - Endoscopic Accessories
Avanos2508 (EP1,EP2) - Cytology Brush
Avanos2508 (EP1,EP2) - MIC-KEY and MIC Transgastric Jejunal feeding tubes
Avanos2508 (EP1,EP2) - KimVent Microcuff
Teleflex (EP2) - Pediatric Two-Lumen Hemodialysis Catherization Kit
Merit1383 (TM) - ReSolve Locking Drainage Catheter
AmericanCatheter5917 (SP) - American Catheter
Merit1383 (TM) - Cen-Step Centesis Catheter
Auris9616 (TM) - Monarch Platform
Atrium1623 (NR) - Chest Drain Accessories
Ursel11054 (MN) - Thora-Vent Thoracic Vent
PFMMedical6614 (TM) - Asept; Jet-Vac
Avanos2508 (EP1,EP2) - Kimberly-Clark Microcuff
Avanos2508 (EP1,EP2) - Epidural Tray
Avanos2508 (EP1,EP2) - Universal Block Tray
Avanos2508 (EP1,EP2) - Spinal Tray
Avanos2508 (EP1,EP2) - Myelogram Trays
Avanos2508 (EP1,EP2) - Epi-Spinal Trays
Avanos2508 (EP1,EP2) - PMP Kits and Catheters
Teleflex (EP2) - Percutaneous Sheath Introducer
Cordis1973 (EP1, EP2) - AVANTI+ Catheter Sheath Introducer
Merit1383 (TM) - K04 - Tubing Kit
Merit1383 (TM) - K08- Fluid Management Kit
Avanos2508 (EP1,EP2) - EASI-LAV
PFMMedical6614 (TM) - VETA Peritoneal Dialysis Introducer Kit (Ref M7230)
Primo3300 (NR) - Nico BrainPath Approach Procedure Pack (Domestic US)
Ranfac3098 (NR) - Ranfac Injection Needle
Avanos2508 (EP1,EP2,NT) -MIC-KEY G
Avanos2508 (EP1,EP2,NT) - MIC and MIC-KEY G-Tube and Extension Sets
Avanos2508 (EP1,EP2) - CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
Neilmed6807 (NT) - NeilMed Clear Canal Earwax Complete Removal Kit - All Natural
Ortho1399 (SN),EP1* - Ortho Development Balanced Knee System
Avanos2508 (EP1,EP2) - Syringe
Avanos2508 (EP1,EP2) - MIC-KEY*
Avanos2508 (EP1,EP2) - MIC*
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Device in the United States for Export Only