BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VariSource iX(t)

    DI: 00856545006034 · Model: 1.2 · VARIAN MEDICAL SYSTEMS UK HOLDINGS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VariSource iX(t)
    Primary DI
    00856545006034
    Version / Model
    1.2
    Catalog Number
    AL19004-001
    Company Name
    VARIAN MEDICAL SYSTEMS UK HOLDINGS LIMITED
    Labeler DUNS
    516270597
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    35b1e9e6-622f-4a14-b51c-fc3358b71bee

    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
    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
    No

    Product Codes

    Code Name
    JAQ System, applicator, radionuclide, remote-controlled

    GMDN Terms

    Code Name
    38300 Remote-afterloading brachytherapy system

    Identifiers

    Type ID
    Primary 00856545006034

    Premarket Submissions

    Submission Number Supplement Number
    K122236 000