BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VersaWrap Tendon Protector

    DI: B454VTP22011 · Model: VTP2201 · Alafair Biosciences, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    VersaWrap Tendon Protector
    Primary DI
    B454VTP22011
    Version / Model
    VTP2201
    Catalog Number
    VTP2201
    Company Name
    Alafair Biosciences, Inc.
    Labeler DUNS
    968882709
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-23
    Public Version
    2
    Public Version Date
    2024-07-29
    Public Version Status
    Update
    Public Device Record Key
    81633b0e-b0b8-47ac-b474-2750e972b42f

    Device Description

    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.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
    FTM Mesh, Surgical

    GMDN Terms

    Code Name
    35671 Tendon spacer

    Identifiers

    Type ID
    Primary B454VTP22011

    Device Sizes

    Type Value Unit Text
    Length 2 Inch
    Width 2 Inch
    Total Volume 1 Milliliter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius