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

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• 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

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

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