BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    De Soutter Medical

    DI: 05051471204348 · Model: 1295334 · DE SOUTTER MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    De Soutter Medical
    Primary DI
    05051471204348
    Version / Model
    1295334
    Catalog Number
    1295334
    Company Name
    DE SOUTTER MEDICAL LIMITED
    Labeler DUNS
    458064144
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-01-01
    Public Version
    1
    Public Version Date
    2024-01-09
    Public Version Status
    New
    Public Device Record Key
    8847cee7-9104-4f45-a6f4-1ef17d65e331

    Device Description

    DBR-800 STERNUDRIVE OSCILLATING SAW HANDPIECE -STRAIGHT CASE

    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
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GEY Motor, Surgical Instrument, Ac-Powered

    GMDN Terms

    Code Name
    66243 Bone/joint surgical power tool motorized handpiece/set, electric, reusable

    Identifiers

    Type ID
    Primary 05051471204348