FDA Registration
Active
🇭🇳 Honduras
O&M Halyard Honduras S.A de C.V.
Reg #: 9680646
·
FEI: 1000582923
·
Expires 2026
Products
5
Proprietary Names
12
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- O&M Halyard Honduras S.A de C.V.
- Registration Number
- 9680646
- FEI Number
- 1000582923
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CARRETERA TEGUCIGALPA,
- City
- VILLANEVA Cortes
- Country
- HN
Regulatory Submissions
- 510(k) Number
- K162930
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 |
|---|---|---|---|---|---|
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2018-05-02 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2018-05-02 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2018-05-02 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2018-05-18 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2018-04-27 |
Proprietary Names
SURGICAL GOWN
AERO BLUE SURGICAL GOWN
GOWN, DRAPE PACKS
SURGICAL DRAPE HALYARD
ISOLATION SURGICAL GOWN
Aero Blue Performance Surgical Gowns
Aero Chrome Breathable Performance Surgical Gown
HALYARD BASICS SURGICAL GOWN
Aero Chrome Select
HALYARD PROCEDURE GOWN
HALYARD GOWN
HALYARD ULTRA SURGICAL GOWN
Establishment Types
Manufacture Medical Device