FDA Registration
Active
🇺🇸 United States
XenMatrix
Reg #: 3005636544
·
FEI: 3005636544
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BARD SHANNON LIMITED
- Registration Number
- 3005636544
- FEI Number
- 3005636544
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SAN GERONIMO INDUSTRIAL PARK, Km. 76.7 Lot #1 Road #3 Bo. Rio Abajo
- City
- HUMACAO
- State
- PR
- ZIP
- 00791
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162193
Owner / Operator
- Firm Name
- C. R. Bard, Inc.
- Operator Number
- 2212754
- Address
- 1 Becton Drive
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2017-02-16 |
| Collagen Surgical Mesh Containing Drugs | PIJ | Class 2 | General, Plastic Surgery | No | 2017-02-16 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2017-02-16 |
Proprietary Names
XenMatrix
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)