VersaWrap Tendon Protector VTP1201

GUDID B454VTP12011

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.

ALAFAIR BIOSCIENCES, INC

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Primary Device IDB454VTP12011
NIH Device Record Keya43be059-2d1d-4c8c-a6c0-990fce574921
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersaWrap Tendon Protector
Version Model NumberVTP1201
Catalog NumberVTP1201
Company DUNS968882709
Company NameALAFAIR BIOSCIENCES, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
Width2 Inch
Total Volume1 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB454VTP12011 [Primary]

FDA Product Code

FTMMesh, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-22
Device Publish Date2020-10-14

On-Brand Devices [VersaWrap Tendon Protector]

B454VTP22010VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon in
B454VTP12011VersaWrap Tendon Protector (K200311) is indicated for the management and protection of tendon in
B454VTP22011VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon in

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