FDA Registration
Active
🇺🇸 United States
Baxter (SDB) - Veritas Collagen Matrix
Reg #: 2030598
·
FEI: 1000518731
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Synergy Health AST, LLC
- Registration Number
- 2030598
- FEI Number
- 1000518731
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9020 Activity Rd Ste D
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92126
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062915
Owner / Operator
- Firm Name
- Synergy Health AST, LLC
- Operator Number
- 10028672
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Collagen, Staple Line Reinforcement | OXE | Class 2 | General, Plastic Surgery | No | 2012-12-11 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2012-12-11 |
| Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction | OXB | Class 2 | General, Plastic Surgery | No | 2012-12-11 |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | PAJ | Class 2 | General, Plastic Surgery | No | 2012-12-11 |
Proprietary Names
Baxter (SDB) - Veritas Collagen Matrix
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)