VersaWrap

FDA UDI

Class II (US FDA UDI)

by Alafair Biosciences, Inc.

Identity

Trade Name: VersaWrap FDA UDI
Generic Name: Tendon spacer FDA UDI
Device Name: 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. FDA UDI
Model / Reference: VTP-1201 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: VTP-1201 FDA UDI
Primary DI / UDI-DI: B454VTP12010 FDA UDI
FDA Product Code: JXI FDA UDI
FTM FDA UDI
GMDN Term: Tendon spacer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5275 FDA UDI
878.3300 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 1 Inch FDA UDI
Width — 2 Inch FDA UDI
Total Volume — 1 Milliliter FDA UDI
Length — 2.5 Centimeter FDA UDI
Width — 5 Centimeter FDA UDI

Category: Nerve guide, synthetic polymer, bioabsorbable Tendon spacer

VersaWrap by Alafair Biosciences, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Tendon spacer.

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Tenoglide® — Integra Lifesciences Corp. · Class II
Geistlich Nexo-Gide® — Geistlich Pharma AG · Class II
Geistlich Nexo-Gide® — Geistlich Pharma AG · Class II
InSpace™ — ORTHO-SPACE LTD · Class II

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 0d3ba45f-eb72-436e-abb9-a60207faab7c 36 fields · synced May 31, 2026