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    FDA UDI In Commercial Distribution 🇺🇸 United States

    SpeedControl SC1 (M-UK1023)

    DI: J021303870021 · Model: 30387002 · W & H Dentalwerk Bürmoos GmbH
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SpeedControl SC1 (M-UK1023)
    Primary DI
    J021303870021
    Version / Model
    30387002
    Company Name
    W & H Dentalwerk Bürmoos GmbH
    Labeler DUNS
    300238441
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-12
    Public Version
    1
    Public Version Date
    2023-10-20
    Public Version Status
    New
    Public Device Record Key
    a98e57aa-1106-4ff9-a8f0-71e808b399ac

    Device Description

    Medical Surgical Unit (230V) for RIWOSpine

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
    DZI Drill, Bone, Powered
    GEY Motor, Surgical Instrument, Ac-Powered
    HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

    GMDN Terms

    Code Name
    41264 Surgical power tool system control unit, line-powered

    Identifiers

    Type ID
    Direct Marking J021303870020
    Primary J021303870021