BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Minimally Invasive Spine Surgery Instruments

    DI: 14719878713099 · Model: MSI-02 · Taiwan Main Orthopaedic Biotechnology Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Minimally Invasive Spine Surgery Instruments
    Primary DI
    14719878713099
    Version / Model
    MSI-02
    Company Name
    Taiwan Main Orthopaedic Biotechnology Co., Ltd.
    Labeler DUNS
    658875222
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-02
    Public Version
    1
    Public Version Date
    2024-12-10
    Public Version Status
    New
    Public Device Record Key
    4e5b3bae-bbd8-4c7e-854f-12ade8a6556a

    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
    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
    SBF Orthopedic Augmented Reality

    GMDN Terms

    Code Name
    61496 Surgical planning/navigation-enhancement system

    Identifiers

    Type ID
    Primary 14719878713099