BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BATTERY PACK, KLS-SD-1000, SINGLE

    DI: 00862377000140 · Model: KLS-BP-001 · PRO-DEX, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BATTERY PACK, KLS-SD-1000, SINGLE
    Primary DI
    00862377000140
    Version / Model
    KLS-BP-001
    Company Name
    PRO-DEX, INC.
    Labeler DUNS
    849370358
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-29
    Public Version
    2
    Public Version Date
    2023-06-14
    Public Version Status
    Update
    Public Device Record Key
    77b16609-1ba0-4661-b53e-c5c0481f477b

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEY Motor, Surgical Instrument, Ac-Powered
    GXL Screwdriver, Skullplate
    HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

    GMDN Terms

    Code Name
    48058 Disposable battery pack

    Identifiers

    Type ID
    Package 10862377000147
    Primary 00862377000140