FDA.reportPublic FDA data

VersaWrap Tendon Protector

Primary DI
B454VTP12011
Brand
VersaWrap Tendon Protector
Company
Alafair Biosciences, Inc.
Model
VTP1201
Catalog number
VTP1201
Device 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.
Published
2020-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B454VTP12011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tendon spacerAn implantable device intended to be used to physically isolate a tendon so that it can function without adhering to adjacent tissue.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1Inch
Total Volume1Milliliter
Width2Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968882709
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B454VTP12G10VersaCoat Flowable HydrogelVTP-12G12025-12-21
B454VTP44G20VersaCoat Flowable HydrogelVTP-44G22025-11-21
B454VSC10VersaWrapVSC-1VSC-12024-06-10
B454VTP12010VersaWrapVTP-1201VTP-12012020-11-01
B454VTP22010VersaWrapVTP-2201VTP-22012016-12-15
B454VTP22011VersaWrap Tendon ProtectorVTP2201VTP22012020-10-23

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