FDA Registration
Active
🇺🇸 United States
Synergy Health AST, LLC
Reg #: 3009882464
·
FEI: 3009882464
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Synergy Health AST, LLC
- Registration Number
- 3009882464
- FEI Number
- 3009882464
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7225 N Noah Dr
- City
- Saxonburg
- State
- PA
- ZIP
- 16056
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091499
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 | FTM | Class 2 | General, Plastic Surgery | No | 2012-12-26 |
| Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction | OXB | Class 2 | General, Plastic Surgery | No | 2012-12-26 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2012-12-26 |
| Mesh, Surgical, Collagen, Staple Line Reinforcement | OXE | Class 2 | General, Plastic Surgery | No | 2012-12-26 |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | PAJ | Class 2 | General, Plastic Surgery | No | 2012-12-26 |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | Class 2 | General, Plastic Surgery | No | 2012-12-26 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)