FDA Registration
Active
🇲🇽 Mexico
La Ada De Acuna, S. de. R. L. de C. V.
Reg #: 3005997949
·
FEI: 3005997949
·
Expires 2026
Products
8
Proprietary Names
14
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- La Ada De Acuna, S. de. R. L. de C. V.
- Registration Number
- 3005997949
- FEI Number
- 3005997949
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- AV. HIDALGO No. 6 ESQ., BLVD. LUIS DONALDO COLOSIO
- City
- COL.EDUCATIVA,NOGALES Sonora
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K093115
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
- 470 3647147
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2018-05-18 |
| 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 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2018-05-31 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2025-08-25 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2022-02-15 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2018-05-02 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2018-04-20 |
Proprietary Names
HALYARD BASICS SURGICAL GOWN
HALYARD PROCEDURE GOWN
SURGICAL DRAPE
Surgical Packs
Anesthesia Breathing Circuit Kit (Adult & Pediatric)
General Surgery Tray
HALYARD ULTRA SURGICAL GOWN
THERMAL REGULATING SYSTEM
Surgical Drape
Equipment Covers
Surgical Drapes and/or accessories
Back Table Covers
Halyard Gown
Surgical Drapes and/or accessories (Stockinette Drapes)
Establishment Types
Manufacture Medical Device