BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HOFFMANN

    DI: 07613327072402 · Model: 4922-1-002 · Stryker Trauma SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HOFFMANN
    Primary DI
    07613327072402
    Version / Model
    4922-1-002
    Catalog Number
    4922-1-002
    Company Name
    Stryker Trauma SA
    Labeler DUNS
    481999654
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2019-03-21
    Public Version Status
    Update
    Public Device Record Key
    9aca4add-650e-4023-8561-d6ab9719bf08

    Device Description

    Disposable Thumb Wheel

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    KTT APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

    GMDN Terms

    Code Name
    35647 External orthopaedic fixation system, reusable

    Identifiers

    Type ID
    Package 37613327072403
    Primary 07613327072402

    Premarket Submissions

    Submission Number Supplement Number
    K122284 000