BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vaginal CT/MR Multi Channel Applicator

    DI: 08717213051348 · Model: 110779P01-01 · Nucletron B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vaginal CT/MR Multi Channel Applicator
    Primary DI
    08717213051348
    Version / Model
    110779P01-01
    Company Name
    Nucletron B.V.
    Labeler DUNS
    415269930
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-23
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    8551319a-5a90-4ac4-b8e5-fe2d086aa939

    Device Description

    Perineal Bar Lever

    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 Safe
    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
    No

    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
    Direct Marking 08717213023901
    Primary 08717213051348

    Customer Contacts

    Phone
    +1(770)300-9725
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K111973 000