FDA Registration
Active
🇺🇸 United States
VersaWrap
Reg #: 3012669262
·
FEI: 3012669262
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ALAFAIR BIOSCIENCES, INC.
- Registration Number
- 3012669262
- FEI Number
- 3012669262
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6101 W. Courtyard Dr., Ste 1-225
- City
- Austin
- State
- TX
- ZIP
- 78730
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240817
Owner / Operator
- Firm Name
- Alafair Biosciences, Inc.
- Operator Number
- 10052283
- Address
- 6101 West Courtyard Drive, Suite #1-225
- City
- Austin
- State
- TX
- Postal Code
- 78730
- Country
- US
- Correspondent
- Sarah Mayes
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | OWW | Class 2 | General, Plastic Surgery | No | 2024-12-04 |
Proprietary Names
VersaWrap
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device