ALAFAIR BIOSCIENCES, INC

Address:6101 W. Courtyard Dr.,Austin,TX,78730,US

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Premarket Exempt
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- Catalog Number : VTP-1201

Device Description : VersaWrap is an absorbable implant (device), designed to serve as an interface b 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.

Device Class : 2

Duns Number: 968882709

Premarket Exempt : No

Product Code : JXI, FTM

Prescription Use : Yes

Device Count : 1

Device Description : VersaWrap Tendon Protector (K200311) is indicated for the management and protect 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.

Device Class : 2

Duns Number: 968882709

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

- Catalog Number : VTP-2201

Device Description : VersaWrap is an absorbable implant (device), designed to serve as an interface b 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.

Device Class : 2

Duns Number: 968882709

Premarket Exempt : No

Product Code : JXI, FTM, OWW

Prescription Use : Yes

Device Count : 1

Device Description : VersaWrap Tendon Protector (K160364) is indicated for the management and protect 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.

Device Class : 2

Duns Number: 968882709

Premarket Exempt : No

Product Code : OWW, FTM

Prescription Use : Yes

Device Count : 1