VersaWrap Tendon Protector VTP2201

GUDID B454VTP22011

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.

ALAFAIR BIOSCIENCES, INC

Tendon spacer

Primary Device ID	B454VTP22011
NIH Device Record Key	81633b0e-b0b8-47ac-b474-2750e972b42f
Commercial Distribution Status	In Commercial Distribution
Brand Name	VersaWrap Tendon Protector
Version Model Number	VTP2201
Catalog Number	VTP2201
Company DUNS	968882709
Company Name	ALAFAIR BIOSCIENCES, INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B454VTP22011 [Primary]

FDA Product Code

OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-11-02
Device Publish Date	2020-10-23

On-Brand Devices [VersaWrap Tendon Protector]

B454VTP22010	VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon in
B454VTP12011	VersaWrap Tendon Protector (K200311) is indicated for the management and protection of tendon in
B454VTP22011	VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon in