BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LexTOME

    DI: 04589761815819 · Model: MUA00049 · MEDMETALEX CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    30

    Basic Information

    Brand Name
    LexTOME
    Primary DI
    04589761815819
    Version / Model
    MUA00049
    Catalog Number
    MUA00049
    Company Name
    MEDMETALEX CO., LTD.
    Labeler DUNS
    718085432
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    30
    Record Status
    Published
    Publish Date
    2023-03-31
    Public Version
    1
    Public Version Date
    2023-04-10
    Public Version Status
    New
    Public Device Record Key
    fe9412fa-ca10-4b71-82b0-99e444cb8f6f

    Device Description

    ACETABULAR REAMER SET

    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HTO Reamer

    GMDN Terms

    Code Name
    32848 Acetabular orthopaedic reamer

    Identifiers

    Type ID
    Primary 04589761815819
    Unit of Use 4569951110009