FDA Registration
Active
🇺🇸 United States
Non-absorbable Surgical Sutures: Polyblend, Polyester, Silk Propolyene, Nylon
Reg #: 1062741
·
FEI: 3000302153
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)
- Registration Number
- 1062741
- FEI Number
- 3000302153
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 439 Industrial Ln
- City
- BIRMINGHAM
- State
- AL
- ZIP
- 35211
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100006
Owner / Operator
- Firm Name
- BAXTER HEALTHCARE CORPORATION
- Operator Number
- 1417572
- Address
- One Baxter Parkway
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Maha Nolasco
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2015-12-07 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2015-12-07 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2015-12-07 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2015-12-07 |
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | Class 2 | General, Plastic Surgery | No | 2015-12-07 |
Proprietary Names
Non-absorbable Surgical Sutures: Polyblend, Polyester, Silk Propolyene, Nylon
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility