VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
Alafair Biosciences
ALAFAIR BIOSCIENCES, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012669262 | 3012669262 | ALAFAIR BIOSCIENCES, INC. | 1 | N | 2026-01-01 | 6101 W. Courtyard Dr. Ste 1-225 Austin TX US 78730 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 196610 | 1834273348 | K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | OWW | 2025-07-18 |
| 196610 | 1320177420 | K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | JXI | 2025-07-22 |
| 196610 | 1604666032 | K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | JXI | 2025-07-17 |
| 196610 | 1896963412 | K240817 | VersaWrap | OWW | 2024-06-14 |
| 196610 | 1067472953 | K232029 | VersaWrap Nerve Protector | JXI | 2023-11-02 |
| 196610 | 1549605499 | K213163 | VersaWrap | FTM | 2021-10-29 |
| 196610 | 1659220502 | K203600 | VersaWrap | FTM | 2021-03-09 |
| 196610 | 1384283747 | K201631 | VersaWrap Nerve Protector | JXI | 2020-09-14 |
| 196610 | 1105881372 | K200311 | VersaWrap Tendon Protector | FTM | 2020-03-06 |
| 196610 | 1050636177 | K160364 | VersaWrap Tendon Protector | OWW | 2016-06-10 |
Product Codes Associated With Registrations#
PMN#
VersaWrap
Alafair Biosciences, Inc.
VersaWrap Nerve Protector
Alafair Biosciences, Inc.
VersaWrap
Alafair Biosciences Inc
VersaWrap
Alafair Biosciences Inc
VersaWrap Nerve Protector
Alafair Biosciences Inc
VersaWrap Tendon Protector
Alafair Biosciences Inc
VersaWrap Tendon Protector
Alafair Biosciences Inc
GUDID#
VersaCoat Flowable Hydrogel - VTP-12G1
2025-12-21
VersaCoat Flowable Hydrogel - VTP-44G2
2025-11-21
VersaWrap - The Wetting Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The Wetting Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.
2024-06-10
VersaWrap - VersaWrap is an absorbable implant (device), designed to serve as an interface between target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap 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.
2016-12-15
VersaWrap - VersaWrap is an absorbable implant (device), designed to serve as an interface between target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap 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.
2020-11-01
VersaWrap Tendon Protector - VersaWrap Tendon Protector (K200311) is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. It is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap is a thin membrane of alginate and glycosaminoglycan and is easy to handle, conformable, and is designed for easy placement under, around, or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches.
2020-10-14
VersaWrap Tendon Protector - VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. It is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap is a thin membrane of alginate and glycosaminoglycan and is easy to handle, conformable, and is designed for easy placement under, around, or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches.
2020-10-23