BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Isomedix Operations Inc.

    Reg #: 1650907 · FEI: 3002681132 · Expires 2026
    View on FDA
    Products
    72
    Proprietary Names
    105
    Establishment Types
    2
    Classifications
    72

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    Registration Details

    Registration Name
    Isomedix Operations Inc.
    Registration Number
    1650907
    FEI Number
    3002681132
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1175 Isuzu Pkwy
    City
    GRAND PRAIRIE
    State
    TX
    ZIP
    75050
    Country
    US

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    9072619
    Address
    5960 Heisley Road, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Arthroscope HRX
    Device, Patient Transfer, Powered FRZ
    Vitrectomy Kit QDY
    Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed NUJ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Apparatus, Cautery, Radiofrequency, Ac-Powered HQR
    Vitrectomy, Instrument Cutter MLZ
    Unit, Phacofragmentation HQC
    Lens, Guide, Intraocular KYB
    Tape And Bandage, Adhesive KGX
    Staple, Implantable GDW
    Stapler, Surgical GAG
    Applicator, Absorbent Tipped, Sterile KXG
    Bronchoscope (Flexible Or Rigid) EOQ
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Cardiac Ablation Percutaneous Catheter LPB
    Accessories, Cleaning Brushes, For Endoscope MNL
    Iol Tray QDV
    Introducer, Catheter DYB
    Photocoagulator And Accessories HQB
    Cannula, Trocar, Ophthalmic NGY
    Cannula, Ophthalmic HMX
    Instrument, Vitreous Aspiration And Cutting, Ac-Powered HQE
    System, Peritoneal, Automatic Delivery FKX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Surgical, Computer Controlled Instrument NAY
    Laparoscope, General & Plastic Surgery GCJ
    Clip, Implantable FZP
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Set, Administration, For Peritoneal Dialysis, Disposable KDJ
    Instrument, Ultrasonic Surgical LFL
    Transducer, Ultrasonic, Diagnostic ITX
    System, Applicator, Radionuclide, Manual IWJ
    System, Applicator, Radionuclide, Remote-Controlled JAQ
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Accessories, Blood Circuit, Hemodialysis KOC
    Single-Use Reprocessed Ultrasonic Surgical Instruments NLQ
    Apparatus, Suturing, Stomach And Intestinal FHM
    Laparoscope, General & Plastic Surgery, Reprocessed NLM
    Protector, Transducer, Dialysis FIB
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Ophthalmic Femtosecond Laser OOE
    Gauze / Sponge,Nonresorbable For External Use NAB
    Endoscope Channel Accessory ODC
    Endoscopic Irrigation/Suction System OCX
    Electrocautery, Gynecologic (And Accessories) HGI
    Sleeve, Limb, Compressible JOW
    Endoilluminator MPA
    Drape, Patient, Ophthalmic HMT
    Phaco Kit QDW
    Hysteroscope (And Accessories) HIH
    Eye Tray OJK
    Keratome, Ac-Powered HNO
    Oximeter, Reprocessed NLF
    Drape, Surgical, Exempt PUI
    Clamp, Surgical, General & Plastic Surgery GDJ
    Autonomous Extracorporeal Blood Leak Detector/Alarm ODX
    Hemodialysis System For Home Use ONW
    Surgical Eye Tray PZG
    Computer, Diagnostic, Programmable DQK
    Tourniquet, Pneumatic KCY
    Electrode, Pacemaker, Temporary LDF
    General Surgery Tray LRO
    Pump, Air, Non-Manual, For Endoscope FEQ
    Endoscopic Tissue Approximation Device OCW
    Laser, Ophthalmic HQF
    Needle, Assisted Reproduction MQE
    Oximeter DQA
    Catheter, Intracardiac Mapping, High-Density Array MTD

    Proprietary Names

    StrykerSustainability (GP) - Reprocessed Powered Patient Transfer Device Johnson & Johnson (GP) - Band-Aid Insulet5490 (PL) - PodPals Adhesive Overlay Insulet5490 (PL) - Adhesive Overlay J&J2483 (GP) - Band-Aid Intuitive5779 (SDA,GP) - 19G Biopsy Needle Intuitive5779 (SDA,GP) - Vision Probe Adapter Intuitive5779 (SDA,GP) - 21G Biopsy Needle Intuitive5779 (SDA,GP) - 23GBiopsy Needle Intuitive5779 (SDA,GP) - Swivel Connector Medivators2752 (GP) - Defendo Cleaning Adapter Ethicon (SDA,GP) - ETHICONTM 4000 45mm Stapler Ambu10292 (GP) - aScope 4 Broncho Large 5.8/2.8 Ambu aScope 4 Broncho Regular 5/2.2 Ambu aScope 4 Broncho Slim 3.8/1.2 Civco3930 (GP) - omniTRAX(TM) Active Patient Tracker Intuitive5779 (SDA,GP) - Xi 8mm Synchroseal Ambu10292 (GP) - Ambu aScope 4 RhinoLaryngo Slim Ethicon (SDA,GP) - ETHICON™ 4000 Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical Civco3930 (GP) - Disposable Template Civco3930 (GP) - Verza Needle Guide Intuitive5779 (SDA,GP) - MCS Tip Cover Intuitive5779 (SDA,GP) - Stapler Sheath StrykerSustainability (GP) - Reprocessed HARMONIC 1100 Shears Intuitive5779 (SDA,GP) - Xi Single-Site Cannula Seal Intuitive5779 (SDA,GP) - Xi Single-Site Port Intuitive5779 (SDA,GP) - Xi Single Site Bipolar Maryland Intuitive_5779 (SDA,GP) - Xi Vessel Sealer Extend DORC10527 (PL) - Phacoemulsification / Vitrectomy System Ambu10292 (GP) Ambu aScope 4 Cysto Civco3930 (GP) - PROCover StrykerSustainability (GP) - Reprocessed HARMONIC 700 Shears Ambu10292 (GP) - Ambu aScope 4 RhinoLaryngo Intervention Intuitive5779 (SDA,GP) - Si Cannula Seal Intuitive_5779 (SDA,GP) - 8mm Stapler Medivators2752 (GP) - SCISSORS INSERT, HOOK, 45CM, 10/BOX Medivators2752 (GP) - SCISSORS INSERT, CVD METZ, 45CM, 10/BOX Medivators2752 (GP) - SCISSORS INSERT, HOOK, 36CM, 10/BOX Medivators2752 (GP) - SCISSORS INSERT, MINI METZ, 45CM, 10/BOX Medivators2752 (GP) - SCISSORS INSERT, CVD METZ, 36CM, 10/BOX Medivators2752 (GP) - SCISSORS INSERT, MINI METZ, 36CM, 10/BOX Intuitive5779 (SDA,GP) - Xi Harmonic ACE BioMed3889 (PL) - Rylon-1 J&J2483 (GP) - Band-Aid; Johnson & Johnson Red Cross Medivators2752 (GP) - DEFENDO Air/Water/Suction and Biopsy Valves and Kits (1003xx); DEFENDO Valve and Connector Kit StrykerSustainability (GP) - Reprocessed Endoscopic Trocars and Sleeves Medivators2752 (GP) - Endogator Irrigation Pump Model EGP-100 Ethicon (SDA,GP) - Electrosurgical, Cutting & Coagulation & Accessories Civco3930 (GP) - L25 Series Needle Guide Civco3930 (GP) - Neoguard Medivators2752 (GP) - SWITCH-BLADEMINI-METZENBAUM SCISSOR TIP Medivators2752 (GP) - SWITCH-BLADEHOOK SCISSOR TIP Medivators2752 (GP) - SWITCH-BLADESTRAIGHT METZENBAUM SCISSOR TIP Medivators2752 (GP) - SWITCH-BLADE CURVED METZENBAUM SCISSOR TIP Medivators2752 (GP) - SWITCH-BLADE™MINI METZENBAUM CLICK-FIT™ SCISSOR TIP Medivators2752 (GP) - SWITCH-BLADE™STRAIGHT METZENBAUM CLICK-FIT™ SCISSOR TIP Medivators2752 (GP) - SWITCH-BLADE™CURVEDMETZENBAUM CLICK-FIT™ SCISSOR TIP Medivators2752 (GP) - DEFENDO AirWater Suction Valve DEFENDO AirWaterSuction Biopsy Valve DEFENDO Valve Connector Kit StrykerSustainability (GP) - Reprocessed Compression Sleeve StrykerSustainability (GP) - Reprocessed Compression Sleeves Intuitive5779 (SDA,GP) - Si Harmonic ACE Insert Medivators2752 (GP) - Endo Smartcap StrykerSustainability (GP) - Reprocessed MyoSure LITE Tissue Removal Device StrykerSustainability (GP) - Reprocessed MyoSure XL Tissue Removal Device for Fluent StrykerSustainability (GP) - Reprocessed MyoSure REACH Tissue Removal Device StrykerSustainability (GP) - Reprocessed MyoSure XL Tissue Removal Device StrykerSustainability (GP) - Reprocessed MyoSure Tissue Removal Device Intuitive5779 (SDA,GP) - Xi Column Drape Intuitive5779 (SDA,GP) - Xi Instrument Arm Drape Ethicon (SDA,GP) - Staple, Implantable StrykerSustainability (GP) - REPROCESSED DILATING TIP TROCARS Intuitive5779 (SDA,GP) - Xi Single Site Fenestrated Bipolar Forceps Ethicon (SDA,GP) - Surgical Stapler StrykerSustainability (GP) - Reprocessed Nellcor Pulse Oximeter Sensor Civco3930 (GP) - Active Fiducial Marker; EMT System; eTRAX Needle System; eTRAX Variable Angle Needle Guide Civco3930 (GP) - General Purpose Sensor; ViruTRAX Instrument Navigator Intuitive5779 (SDA,GP) - IS4200 Arm 4 Proximal Drape Protech3048 (GP) - 7894-6 - LEVO STERILE CERVICAL DRAPE W/WINDOW 6CS Protech3048 (GP) - 6855AUD-6 - HANA ANTERIOR HIP UPPER STERILE DRAPE, 6 Civco3930 (GP) - Envision Medivators2752 (GP) - Endo Gator Hybrid Tubing Kits Medivators2752 (GP) - Defendo Y-Opsy Irrigator Intuitive5779 (GP,SDA) - Xi Stapler 45 Reload Intuitive_5779 (SDA,GP) - SP Instrument Sheath Intuitive_5779 (SDA,GP) - SP Camera Instrument Sheath Intuitive_5779 (SDA,GP) - SP Monopolar Scissors Tip StrykerSustainability (GP) - Reprocessed Tourniquet Cuff Medivators2752 (GP) - Defendo Fujifilm 500/600 Air/Water, Suction, and Biopsy Valve and ENDOGATOR Connector Medivators2752 (GP) - Defendo Fujifilm 500/600 Air/Water, Suction, and Biopsy Valve Medivators2752 (GP) - Defendo Fujifilm 500/600 Air/Water and Suction Valve Medivators2752 (GP) - Endogator Auxiliary Water Jet Connector; Endogator System Medivators2752 (GP) - ENDOGATOR Single Use Auxiliary Water Jet Connectors BiosenseWebster3941 (SDA,GP) - Interface Cable Medivators2752 (GP) - ENDOGATOR Hybrid Irrigation Tubing Civco3930 (GP) - VitroPRO Civco3930 (GP) - AccuSITE; Infinity; Maggi II Plus; Multi-Pro 2000; Ultra-Pro 3; Ultra-Pro II StrykerSustainability (GP) - Reprocessed Masimo Pulse Oximeter Sensor Civco3930 (GP) - CIV-Clear cover Intuitive_5779 (SDA,GP) - Stapler Reload SureForm™ 60 Intuitive_5779 (SDA,GP) - Stapler SureForm™ 45 Curved-Tip Intuitive_5779 (SDA,GP) - Stapler Reload SureForm™ 45 Intuitive_5779 (SDA,GP) - Stapler SureForm™ 45 Straight-Tip Intuitive_5779 (SDA,GP) - Stapler SureForm™ 60 Instrument Intuitive_5779 (SDA,GP) - Stapler Reload SureForm™ 45 (Grey) Intuitive_5779 (SDA,GP) - Xi Stapler 30 Reload StrykerSustainability (GP) - Reprocessed RD SET Pulse Oximeter Sensor

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Device in the United States for Export Only