BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-Wing Tensioner

    DI: 09421028113458 · Model: 72205271 · ENZTEC LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X-Wing Tensioner
    Primary DI
    09421028113458
    Version / Model
    72205271
    Catalog Number
    72205271
    Company Name
    ENZTEC LIMITED
    Labeler DUNS
    592616445
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-01
    Public Version
    1
    Public Version Date
    2020-12-09
    Public Version Status
    New
    Public Device Record Key
    9eb0221a-0cb2-42c6-8aee-840a4bf0d02b

    Device Description

    Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    44872 Orthopaedic graft tensioner, reusable

    Identifiers

    Type ID
    Primary 09421028113458