FDA Registration
Active
🇭🇳 Honduras
Honduras Kitting, S.A.
Reg #: 3035642068
·
FEI: 3035642068
·
Expires 2026
Products
121
Proprietary Names
126
Establishment Types
1
Classifications
121
Registration Details
- Registration Name
- Honduras Kitting, S.A.
- Registration Number
- 3035642068
- FEI Number
- 3035642068
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CA-5
- City
- Villanueva Cortes
- Country
- HN
Owner / Operator
- Firm Name
- O&M Halyard, Inc.
- Operator Number
- 10057479
- Address
- 1220 Old Alpharetta Rd, Suite 320
- City
- Alpharetta
- State
- GA
- Postal Code
- 30005
- Country
- US
- Correspondent
- Angela Bunn
US Agent
- Business Name
- O&M HALYARD, INC.
- Contact Name
- Angela Bunn
- Address
- 1220 Old Alpharetta Rd Ste 320
- City
- Alpharetta
- State
- GA
- ZIP
- 30005
- Country
- US
- [email protected]
- Phone
- 770 4011697
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clamp, Umbilical | HFW | Class 2 | Obstetrics/Gynecology | No | 2025-01-13 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2025-01-13 |
| Breast Pump Kit | OHH | Class 2 | Obstetrics/Gynecology | No | 2022-02-17 |
| Needle, Spinal, Short Term | MIA | Class 2 | Anesthesiology | No | 2025-01-15 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2025-01-13 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Epidural Anesthesia Kit | OGE | Class 2 | Anesthesiology | No | 2022-02-17 |
| Counter, Sponge, Surgical | LWH | Class 1 | General Hospital | No | 2025-01-13 |
| Suture Removal Kit | MCZ | Class 1 | General, Plastic Surgery | No | 2025-01-15 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2022-02-17 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2022-02-17 |
| Labor And Delivery Kit | MLS | Class 2 | Obstetrics/Gynecology | No | 2022-02-17 |
| Skin Prep Tray | OJU | Class 1 | General, Plastic Surgery | No | 2022-02-17 |
| Burn Kit Without Drug | OJJ | Class 1 | General, Plastic Surgery | No | 2022-02-17 |
| Laparoscopy Kit | FDE | Class 2 | Gastroenterology, Urology | No | 2022-02-15 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2026-04-30 |
| Orthopedic Tray | OJH | Class 1 | General, Plastic Surgery | No | 2022-02-17 |
| Tray, Biopsy, Without Biopsy Instruments | FCH | Class 1 | Gastroenterology, Urology | No | 2022-02-15 |
| Spinal Epidural Anesthesia Kit | OFT | Class 2 | Anesthesiology | No | 2025-01-15 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2025-01-15 |
| Laparoscopic Gastrostomy Kit | PSD | Class 2 | Gastroenterology, Urology | No | 2025-06-11 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2025-01-13 |
| D And C Tray | PKF | Class N | Unknown | No | 2022-02-17 |
| Ear, Nose, And Throat Surgical Tray | OGR | Class 1 | Ear, Nose, Throat | No | 2022-02-17 |
| Decontamination Kit | MAC | Class 1 | General, Plastic Surgery | No | 2025-01-15 |
| Clamp, Circumcision | HFX | Class 2 | Obstetrics/Gynecology | No | 2025-01-15 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2024-07-15 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2025-01-13 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2025-01-15 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2022-02-15 |
| Body Fluids Barrier Kit | OKH | Class 2 | General, Plastic Surgery | No | 2025-01-15 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2025-01-13 |
| Pelvic Exam Kit | MLT | Class 2 | Obstetrics/Gynecology | No | 2022-02-17 |
| General Purpose Dental Tray | OFX | Class 1 | Dental | No | 2022-02-17 |
| Plastic Surgery And Accessories Kit | FTN | Class 1 | General, Plastic Surgery | No | 2022-02-15 |
| Phlebotomy Blood Collection Kit | OFM | Class 2 | Cardiovascular | No | 2025-01-15 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2025-01-15 |
| Catheter Introducer Kit | OFD | Class 2 | Cardiovascular | No | 2025-01-15 |
| Tracheotomy Care Kit | NXA | Class 2 | Anesthesiology | No | 2025-01-15 |
| Nerve Block Tray | OGJ | Class 2 | Anesthesiology | No | 2022-02-17 |
| Cardiac Catheterization Kit | OES | Class 2 | Cardiovascular | No | 2022-02-17 |
| Single Use Instrument Tray | OJV | Class 1 | General, Plastic Surgery | No | 2022-02-17 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2025-01-15 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2025-01-13 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2024-08-21 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-01-15 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2019-01-09 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Dialysis Administration Kit | PEV | Class 2 | Gastroenterology, Urology | No | 2025-01-15 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2024-08-21 |
| Gynecological Laparoscopic Kit | OHD | Class 2 | Obstetrics/Gynecology | No | 2022-02-17 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2025-01-15 |
| Suture Kit | OVN | Class 2 | General, Plastic Surgery | No | 2022-02-17 |
| Myringotomy Procedure Kit | OGS | Class 2 | Ear, Nose, Throat | No | 2025-01-15 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-01-13 |
| Sampler, Amniotic Fluid (Amniocentesis Tray) | HIO | Class 1 | Obstetrics/Gynecology | No | 2024-01-11 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2025-01-15 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2026-04-30 |
| Port Introducer Kit | OKE | Class 2 | General Hospital | No | 2022-02-17 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2025-01-13 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2025-01-13 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2025-01-13 |
| Endoscopic Cholangiogram Kit | NWT | Class 2 | Gastroenterology, Urology | No | 2022-02-17 |
| Laryngoscope Kit | OGH | Class 1 | Anesthesiology | No | 2022-02-17 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Patient Personal Hygiene Kit | NSB | Class 1 | Dental | No | 2019-12-31 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Wound Dressing Kit | MCY | Class 2 | General Hospital | No | 2025-01-15 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2025-01-15 |
| Radiology-Diagnostic Kit | OIP | Class 2 | Radiology | No | 2022-02-21 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2018-04-20 |
| Ct Biopsy Tray | OFG | Class 2 | Cardiovascular | No | 2022-02-17 |
| Umbilical Catheter Insertion Tray | PXJ | Class 2 | General Hospital | No | 2022-02-21 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2024-02-12 |
| Central Venous Catheter Dressing Change Kit | PEZ | Class 2 | General Hospital | No | 2025-01-15 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2025-01-16 |
| Chemotherapy Spill Clean-Up Kit | PWT | Class 1 | General Hospital | No | 2025-01-15 |
| Pen, Marking, Surgical | HRP | Class 1 | Ophthalmic | No | 2025-01-13 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2022-02-17 |
| Pap Smear Kit | OHL | Class 2 | Obstetrics/Gynecology | No | 2025-01-15 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2025-01-15 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2025-01-15 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2025-01-15 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2025-01-13 |
| Custom Anesthesia Tray | OGD | Class 2 | Anesthesiology | No | 2025-01-15 |
| Bladder Irrigation Kit | PPA | Class 2 | Gastroenterology, Urology | No | 2025-01-15 |
| Body Fluid Clean Up Kit | OKG | Class 2 | General, Plastic Surgery | No | 2025-01-15 |
| Tracheostomy Kit | OGW | Class 2 | Anesthesiology | No | 2025-01-15 |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | Class 1 | Pathology | No | 2022-02-17 |
| Dressing Change Tray | OXQ | Class 1 | General Hospital | No | 2022-02-17 |
| Arthrogram Tray | OII | Class 2 | Radiology | No | 2023-11-21 |
| Catheter Care Tray | OHR | Class 2 | Gastroenterology, Urology | No | 2025-01-15 |
| Obstetrical Kit | OKV | Class 2 | Obstetrics/Gynecology | No | 2025-01-15 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2018-05-31 |
| Circumcision Tray | OHG | Class 2 | Obstetrics/Gynecology | No | 2022-02-17 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2025-01-13 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2018-05-02 |
| Blood Specimen Collection Kit (Excludes Hiv Testing) | OFZ | Class 1 | Anesthesiology | No | 2022-02-17 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2025-01-13 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2025-01-13 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2025-01-15 |
| Endoscope Introducer Kit | NWU | Class 2 | Gastroenterology, Urology | No | 2022-02-17 |
| Cardiovascular Surgical Instruments Tray | OFA | Class 1 | Cardiovascular | No | 2025-01-15 |
| Anesthesia Kit | OFQ | Class 2 | Anesthesiology | No | 2022-02-17 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2022-02-17 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2022-02-17 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2025-01-13 |
| Bone Marrow Collection/Transfusion Kit | LWE | Class 2 | Unknown | No | 2025-01-15 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2025-01-15 |
| Central Venous Catheter Tray | OFF | Class 2 | Cardiovascular | No | 2022-02-17 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2025-01-13 |
| Neurological Tray | OJG | Class 1 | Neurology | No | 2022-02-17 |
| Hysterectomy Kit | OJF | Class 2 | Obstetrics/Gynecology | No | 2022-02-17 |
| Tray, Start/Stop (Including Contents), Dialysis | FKG | Class 1 | Gastroenterology, Urology | No | 2022-02-17 |
| Cesarean Section Tray | OHM | Class 2 | Obstetrics/Gynecology | No | 2022-02-17 |
Proprietary Names
Obstetric-gynecologic specialized manual instrument (Clamp, Umbilical)
Light, surgical, accessories
Breast Pump Kit
Anesthesia conduction needle (Needle, Spinal, Short Term)
Manual ophthalmic surgical instrument (Forceps)
TOURNIQUET, NONPNEUMATIC
Epidural Anesthesia Kit
Counter, sponge, surgical
Suture removal kit
Cardiovascular Procedure Kit
I.V. Start Kit
Labor And Delivery Kit
Skin Prep Tray
Burn Kit Without Drug
laparoscopy kit
Orthopedic Tray
Biopsy Tray
Spinal epidural anesthesia kit
Gastrointestinal tube and accessories.
laparoscopic gastrostomy kit
Prosthetic and orthotic accessory (Bandate, Cast)
D And C Tray
Ear, Nose, And Throat Surgical Tray
Decontamination kit
CLAMP, CIRCUMCISION
Cover, Limb
Protector, skin pressure
Intravascular administration set
General Surgery Tray
Body fluids barrier kit
Obstetric-gynecologic general manual instrument (Speculum, Vaginal, Metal)
Pelvic Exam Kit
General Purpose Dental Tray
Plastic Surgery Kit
Plastic Surgery And Accessories Kit
Phlebotomy blood collection kit
Anti fog solution and accessories, endoscopy
Catheter introducer kit
Tracheotomy care kit
Nerve Block Tray
Cardiac Catheterization Kit
Single Use Instrument Tray
Hypodermic single lumen needle.
CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE
HALYARD* Absorbent Table Cover
Electrosurgical, cutting & coagulation & accessories
Tray Liner
Kit, surgical instrument, disposable
Dialysis administration kit
HALYARD* Drawcord Bag, Clear
Gynecological Laparoscopic Kit
Anesthesia conduction needle
Suture Kit
Myringotomy procedure kit
Medical adhesive tape and adhesive bandage (Tape and Bandage, Adhesive)
Sampler, amniotic fluid (amniocentesis tray)
Catheter guide wire
Port Introducer Kit
SYRINGE, IRRIGATING (NON DENTAL)
TRAY, SURGICAL, ENT
BANDAGE, ELASTIC
Endoscopic Cholangiogram Kit
Lyrangoscope Kit
CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
INSTRUMENT, SURGICAL, DISPOSABLE
MediChoice
Gauze / sponge,nonresorbable for external use
Patient Welcome Pack
Hygiene Kit
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Wound dressing kit
Surgical Drape
Radiology-Diagnostic Kit
Equipment Covers
Surgical Drapes and/or accessories
Back Table Covers
Halyard Gown
Surgical Drapes and/or accessories (Stockinette Drapes)
Surgical Packs
CT Biopsy Tray
Umbilical Catheter Insertion Tray
Anesthesia Conduction Kit
Central venous catheter dressing change kit
Intravascular administration set. (Stopcock IV Set)
Chemotherapy Spill Clean-Up Kit
Pen, marking, surgical
Eye Tray
Pap smear kit
TAPE, MEASURING, RULERS AND CALIPERS
Sterilization wrap
Arthroscope
Urinary drainage collection kit, for indwelling catheter
Anesthesia conduction catheter (Custom Anesthesia Tray)
Bladder Irrigation Kit
Body fluid clean up kit
Tracheostomy kit
Blood and Uring Collection Kit (excludes HIV testing)
Dressing Change Tray
Arthrogram tray
Catheter care tray
Obstetrical Kit
Stockinette
Circumcision Tray
ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
AERO BLUE SURGICAL GOWN
Blood Specimen Collection Kit (Excludes Hiv Testing)
Electrode, electrocardiograph
Specimen transport and storage container (Container, Specimen, Non-Sterile)
Peripheral catheter insertion kit
Endoscope Introducer Kit
Cardiovascular surgical instruments tray
Anesthesia Kit
Label Or Tag, Sterile
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Angiography/Angioplasty Kit
Manual surgical instrument for general use (Scissors, General, Surgical)
Vacuum-powered body fluid suction apparatus (Tubing, noninvasive)
Bone marrow collection/transfusion kit
Urine collection kit (excludes HIV testing)
Central Venous Catheter Tray
TRAY, SURGICAL, INSTRUMENT
Retractor, Self-Retaining
Neurological Tray
Hysterectomy Kit
Tray, Start/Stop (Including Contents), Dialysis
Cesarean Section Tray
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)