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    FDA UDI In Commercial Distribution 🇺🇸 United States

    SPARK - Instruments

    DI: 04026575426942 · Model: 319-437/12B · WALDEMAR LINK GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SPARK - Instruments
    Primary DI
    04026575426942
    Version / Model
    319-437/12B
    Company Name
    WALDEMAR LINK GmbH & Co. KG
    Labeler DUNS
    315675488
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-11
    Public Version
    1
    Public Version Date
    2023-01-19
    Public Version Status
    New
    Public Device Record Key
    6a1a701d-e3b4-48fc-9d07-d1dc0f29eddf

    Device Description

    Medullary canal orthopaedic reamer, rigid - Gemini SL Total Knee System

    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
    No
    Has Lot/Batch Number
    Yes
    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
    HTO REAMER

    GMDN Terms

    Code Name
    45115 Medullary canal orthopaedic reamer, rigid

    Identifiers

    Type ID
    Primary 04026575426942