VersaWrap Tendon Protector

FDA UDI

Class II (US FDA UDI)

by Alafair Biosciences, Inc.

Identity

Trade Name: VersaWrap Tendon Protector FDA UDI
Generic Name: Tendon spacer FDA UDI
Device Name: 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. FDA UDI
Model / Reference: VTP1201 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: VTP1201 FDA UDI
Primary DI / UDI-DI: B454VTP12011 FDA UDI
FDA Product Code: FTM FDA UDI
GMDN Term: Tendon spacer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Category: Tendon spacer

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

Similar devices

Also classified as Tendon spacer.

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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

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Manufacturer

Manufacturer: Alafair Biosciences, Inc.

Sources (1)

FDA UDI a43be059-2d1d-4c8c-a6c0-990fce574921 36 fields · synced May 30, 2026