BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ultium

    DI: 00816271020872 · Model: 874GSL · Noraxon U.S.A., Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Ultium
    Primary DI
    00816271020872
    Version / Model
    874GSL
    Company Name
    Noraxon U.S.A., Inc.
    Labeler DUNS
    611243809
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-30
    Public Version
    1
    Public Version Date
    2026-04-07
    Public Version Status
    New
    Public Device Record Key
    47100344-d601-4138-b52d-7295def06957

    Device Description

    Ultium Sports Glove (S/M) – Left

    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
    No

    Product Codes

    Code Name
    KQX Goniometer, Ac-Powered

    GMDN Terms

    Code Name
    63313 Kinesiology/electromyographic sensor set

    Identifiers

    Type ID
    Primary 00816271020872