BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ROSA ONE BRAIN APPLICATION (US)

    DI: 00887868585951 · Model: 3.1.7 · MEDTECH
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ROSA ONE BRAIN APPLICATION (US)
    Primary DI
    00887868585951
    Version / Model
    3.1.7
    Catalog Number
    ROSAS00203
    Company Name
    MEDTECH
    Labeler DUNS
    264502977
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-30
    Public Version
    1
    Public Version Date
    2023-11-07
    Public Version Status
    New
    Public Device Record Key
    7ba1b759-788c-40c2-849b-1864cb392a96

    Device Description

    Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OLO Orthopedic Stereotaxic Instrument
    HAW Neurological Stereotaxic Instrument

    GMDN Terms

    Code Name
    45199 Multi-purpose stereotactic surgery system

    Identifiers

    Type ID
    Primary 00887868585951

    Premarket Submissions

    Submission Number Supplement Number
    K231103 000