BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ALPHA OMEGA MICRODRIVE HOLDER

    DI: 03760244031181 · Model: ROSA-128E · MEDTECH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ALPHA OMEGA MICRODRIVE HOLDER
    Primary DI
    03760244031181
    Version / Model
    ROSA-128E
    Catalog Number
    ROSAS00319
    Company Name
    MEDTECH
    Labeler DUNS
    264502977
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-09
    Public Version
    6
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    cefd9489-e4af-4a20-9ded-11ca0b70cb47

    Device Description

    instrument Rosa 3.0 instrument Rosa 3.1 Alpha Omega microdrive holder

    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
    Yes
    Has Lot/Batch Number
    No
    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
    HAW Neurological Stereotaxic Instrument

    GMDN Terms

    Code Name
    45199 Multi-purpose stereotactic surgery system
    32568 Neurological stereotactic surgery system

    Identifiers

    Type ID
    Primary 03760244031181

    Premarket Submissions

    Submission Number Supplement Number
    K151359 000
    K172444 000
    K182417 000