Honduras Kitting, S.A.

FDA Device Registration & Listing · Villanueva Cortes, HN · Registration 3035642068

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035642068
FEI Number
3035642068
Entity Name
Honduras Kitting, S.A.
City/State/Country
Villanueva Cortes, HN
Establishment Address
CA-5, Villanueva Cortes 21000, HN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
O&M Halyard, Inc. (Owner Number: 10057479)
Owner / Operator Contact Address
1220 Old Alpharetta Rd, Suite 320, Alpharetta, GA 30005, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Surgical Drape 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HFW Clamp, Umbilical Obstetrics/Gynecology Class 2 884.4530 2025-01-13
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2025-01-13
OHH Breast Pump Kit Obstetrics/Gynecology Class 2 884.5160 2022-02-17
MIA Needle, Spinal, Short Term Anesthesiology Class 2 868.5150 2025-01-15
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2025-01-13
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2025-01-13
OGE Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2022-02-17
LWH Counter, Sponge, Surgical General Hospital Class 1 880.2740 2025-01-13
MCZ Suture Removal Kit General, Plastic Surgery Class 1 878.4800 2025-01-15
OEZ Cardiovascular Procedure Kit Cardiovascular Class 2 870.1200 2022-02-17
LRS I.V. Start Kit General Hospital Class 2 880.5200 2022-02-17
MLS Labor And Delivery Kit Obstetrics/Gynecology Class 2 884.4530 2022-02-17
OJU Skin Prep Tray General, Plastic Surgery Class 1 878.4800 2022-02-17
OJJ Burn Kit Without Drug General, Plastic Surgery Class 1 878.4022 2022-02-17
FDE Laparoscopy Kit Gastroenterology, Urology Class 2 876.1500 2022-02-15
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2026-04-30
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2022-02-17
FCH Tray, Biopsy, Without Biopsy Instruments Gastroenterology, Urology Class 1 876.4730 2022-02-15
OFT Spinal Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2025-01-15
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-01-15
PSD Laparoscopic Gastrostomy Kit Gastroenterology, Urology Class 2 876.5980 2025-06-11
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2025-01-13
PKF D And C Tray Unknown Class N N/A 2022-02-17
OGR Ear, Nose, And Throat Surgical Tray Ear, Nose, Throat Class 1 874.4420 2022-02-17
MAC Decontamination Kit General, Plastic Surgery Class 1 878.4014 2025-01-15
HFX Clamp, Circumcision Obstetrics/Gynecology Class 2 884.4530 2025-01-15
IPM Cover, Limb Physical Medicine Class 1 890.3025 2024-07-15
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2025-01-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-01-15
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2022-02-15
OKH Body Fluids Barrier Kit General, Plastic Surgery Class 2 878.4040 2025-01-15
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2025-01-13
MLT Pelvic Exam Kit Obstetrics/Gynecology Class 2 884.4530 2022-02-17
OFX General Purpose Dental Tray Dental Class 1 872.6640 2022-02-17
FTN Plastic Surgery And Accessories Kit General, Plastic Surgery Class 1 878.3925 2022-02-15
OFM Phlebotomy Blood Collection Kit Cardiovascular Class 2 870.2750 2025-01-15
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2025-01-15
OFD Catheter Introducer Kit Cardiovascular Class 2 870.1340 2025-01-15
NXA Tracheotomy Care Kit Anesthesiology Class 2 868.5800 2025-01-15
OGJ Nerve Block Tray Anesthesiology Class 2 868.5140 2022-02-17
OES Cardiac Catheterization Kit Cardiovascular Class 2 870.1200 2022-02-17
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2022-02-17
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2025-01-15
KDT Container, Specimen Mailer And Storage, Sterile Pathology Class 1 864.3250 2025-01-13
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2024-08-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-01-15
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2019-01-09
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2025-01-13
PEV Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5820 2025-01-15
FNY Basin, Emesis General Hospital Class 1 880.6730 2024-08-21
OHD Gynecological Laparoscopic Kit Obstetrics/Gynecology Class 2 884.1720 2022-02-17
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2025-01-15
OVN Suture Kit General, Plastic Surgery Class 2 878.4830 2022-02-17
OGS Myringotomy Procedure Kit Ear, Nose, Throat Class 2 874.3880 2025-01-15
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2025-01-13
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2024-01-11
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-01-15
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2026-04-30
OKE Port Introducer Kit General Hospital Class 2 880.5965 2022-02-17
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2025-01-13
MMO Tray, Surgical, Ent Ear, Nose, Throat Class 1 874.4420 2025-01-13
FQM Bandage, Elastic General Hospital Class 1 880.5075 2025-01-13
NWT Endoscopic Cholangiogram Kit Gastroenterology, Urology Class 2 876.1500 2022-02-17
OGH Laryngoscope Kit Anesthesiology Class 1 868.5540 2022-02-17
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-01-13
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2025-01-13
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2025-01-13
NSB Patient Personal Hygiene Kit Dental Class 1 872.6855 2019-12-31
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-01-13
MCY Wound Dressing Kit General Hospital Class 2 880.5075 2025-01-15
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2025-01-15
OIP Radiology-Diagnostic Kit Radiology Class 2 892.1680 2022-02-21
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2018-04-20
OFG Ct Biopsy Tray Cardiovascular Class 2 870.4075 2022-02-17
PXJ Umbilical Catheter Insertion Tray General Hospital Class 2 880.5200 2022-02-21
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2024-02-12
PEZ Central Venous Catheter Dressing Change Kit General Hospital Class 2 880.5200 2025-01-15
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2025-01-16
PWT Chemotherapy Spill Clean-Up Kit General Hospital Class 1 880.6250 2025-01-15
HRP Pen, Marking, Surgical Ophthalmic Class 1 886.4570 2025-01-13
OJK Eye Tray Ophthalmic Class 2 886.4790 2022-02-17
OHL Pap Smear Kit Obstetrics/Gynecology Class 2 884.4530 2025-01-15
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2025-01-13
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2025-01-15
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2025-01-15
HRX Arthroscope Orthopedic Class 2 888.1100 2025-01-15
FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2025-01-13
OGD Custom Anesthesia Tray Anesthesiology Class 2 868.5120 2025-01-15
PPA Bladder Irrigation Kit Gastroenterology, Urology Class 2 876.5130 2025-01-15

Official Correspondent

Angela Bunn

US Agent Details

Angela Bunn Business: O&M HALYARD, INC. Email: angela.bunn@owens-minor.com Phone: (770) 4011697

Related Public Records

Same Entity

O&M Halyard, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012143814 Southaven Distribution Center Southaven, MS, US
3016849443 O&M Halyard, Inc. (La Ada de Acuna) Del Rio, TX, US
1054380 Halyard North Carolina, LLC LINWOOD, NC, US
9680646 O&M Halyard Honduras S.A de C.V. VILLANEVA Cortes, HN
3005997949 La Ada De Acuna, S. de. R. L. de C. V. COL.EDUCATIVA,NOGALES Sonora, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K936120 Cush Medical Products LABOR AND DELIVERY TRAY 1994-03-30
K900590 Biosearch Medical Products, Inc. BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING 1990-08-02
K102548 Footprint Medical, Inc. FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE 2010-11-26
K955248 United States Endoscopy Group, Inc. U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT 1996-05-21
K872921 Medical Support, Inc. MSS ENTERAL DELIVERY SET 1987-12-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0029-2025 Windstone Medical Packaging, Inc. 1
Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035642068. Last updated year: 2026. Please use registration number 3035642068 when referencing this establishment in official correspondence.
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