FDA Registration
Active
🇲🇽 Mexico
FACE-IT SHIELD
Reg #: 3009746061
·
FEI: 3009746061
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Integra Biotechnical, SA de CV
- Registration Number
- 3009746061
- FEI Number
- 3009746061
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Privada Los Pinos #17030 Interior 15, 16, 17, Colonia Ninos Heroes Este, C.P, Ave. Via Rapida Poniente #16835 Interior 3, Centro Ind. Los Pinos II, Colonia Ninos Heroes Este, C.P.
- City
- Tijuana Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K942022
Owner / Operator
- Firm Name
- Amphenol Critical Medical Technologies, LLC
- Operator Number
- 9030406
- Address
- 9586 Distribution Avenue, Suite F
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Lamont Rohde
US Agent
- Business Name
- Amphenol Critical Medical Technologies, LLC
- Contact Name
- Lamont Rohde
- Address
- 9586 Distribution Avenue, Suite F
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
- [email protected]
- Phone
- 602 7503539
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2005-10-12 |
Proprietary Names
FACE-IT SHIELD
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)