VersaWrap

FDA UDI

Class II (US FDA UDI)

by Alafair Biosciences, Inc.

Identity

Trade Name: VersaWrap FDA UDI
Generic Name: Nerve guide, synthetic polymer, bioabsorbable 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-2201 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-2201 FDA UDI
Primary DI / UDI-DI: B454VTP22010 FDA UDI
FDA Product Code: JXI FDA UDI
FTM FDA UDI
OWW FDA UDI
GMDN Term: Nerve guide, synthetic polymer, bioabsorbable 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: Total Volume — 1 Milliliter FDA UDI
Length — 2 Inch FDA UDI
Width — 2 Inch FDA UDI
Length — 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

Similar devices

Also classified as Tendon spacer.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Alafair Biosciences, Inc.

Sources (1)

FDA UDI ceb7320b-f9ad-421c-b3e8-acb3eb84b3c4 36 fields · synced Jun 8, 2026