BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EXCELSIUS GPS

    DI: 00193982192587 · Model: 6143.1920 · GLOBUS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EXCELSIUS GPS
    Primary DI
    00193982192587
    Version / Model
    6143.1920
    Company Name
    GLOBUS MEDICAL, INC.
    Labeler DUNS
    139105691
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-23
    Public Version
    2
    Public Version Date
    2023-06-19
    Public Version Status
    Update
    Public Device Record Key
    00635de4-107f-451a-ab58-d8b74c824c7d

    Device Description

    Leksell Frame Base Adapter

    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
    No
    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
    OLO Orthopedic stereotaxic instrument
    HAW Neurological stereotaxic Instrument

    GMDN Terms

    Code Name
    38678 Robotic surgical arm system

    Identifiers

    Type ID
    Primary 00193982192587

    Premarket Submissions

    Submission Number Supplement Number
    K200047 000