BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Titanium Colpostat Probe (right), Titanium

    DI: 00816389023697 · Model: GM11006120 · VARIAN MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Titanium Colpostat Probe (right), Titanium
    Primary DI
    00816389023697
    Version / Model
    GM11006120
    Catalog Number
    GM11006120
    Company Name
    VARIAN MEDICAL SYSTEMS, INC.
    Labeler DUNS
    009120817
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-02
    Public Version
    1
    Public Version Date
    2021-02-10
    Public Version Status
    New
    Public Device Record Key
    5c9857af-4cbb-438a-8976-41c8bfbc1f74

    Device Description

    For Titanium Fletcher-style Applicator Set (CT & MR compatible, flexible geometry)

    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
    JAQ System, applicator, radionuclide, remote-controlled

    GMDN Terms

    Code Name
    38407 Vaginal brachytherapy system applicator, remote-afterloading

    Identifiers

    Type ID
    Primary 00816389023697

    Premarket Submissions

    Submission Number Supplement Number
    K952913 000