Identity
- Trade Name
- VersaWrap FDA UDI
- Generic Name
- Nerve guide, synthetic polymer, bioabsorbable FDA UDI
- Device Name
- The VersaWrap wetting Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch. FDA UDI
- Model / Reference
- VSC-1 FDA UDI
- Description
- The VersaWrap wetting Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch. FDA UDI
Identifiers
- Catalog Number
- VSC-1 FDA UDI
- Primary DI / UDI-DI
- B454VSC10 FDA UDI
- FDA Product Code
- JXI FDA UDIFTM FDA UDIOWW FDA UDI
- GMDN Term
- Nerve guide, synthetic polymer, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5275 FDA UDI878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Nerve guide, synthetic polymer, bioabsorbableTendon spacer
VersaWrap by Alafair Biosciences, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alafair Biosciences, Inc.
Sources (1)
- FDA UDI 9ebac965-a212-4b4d-8a4e-ac63f777684c 35 fields · synced May 30, 2026