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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cervical Sleeve IU 6.4mm diameter, 30mm diameter, with marker

    DI: 00816389026032 · Model: GM11011280 · Varian Medical Systems Deutschland GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cervical Sleeve IU 6.4mm diameter, 30mm diameter, with marker
    Primary DI
    00816389026032
    Version / Model
    GM11011280
    Catalog Number
    GM11011280
    Company Name
    Varian Medical Systems Deutschland GmbH
    Labeler DUNS
    332474605
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-22
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    3a676e2a-b2c3-42c6-8f07-8f4a85832d0c

    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
    MR Conditional
    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
    38409 Cervical/intrauterine brachytherapy system applicator, remote-afterloading

    Identifiers

    Type ID
    Primary 00816389026032

    Premarket Submissions

    Submission Number Supplement Number
    K150839 000

    Device Sizes

    Type Value Unit Text
    Length 30 Millimeter