BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Biograph Trinion.X EP5 CT128

    DI: 04068151048056 · Model: 11713856 · SIEMENS MEDICAL SOLUTIONS USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Biograph Trinion.X EP5 CT128
    Primary DI
    04068151048056
    Version / Model
    11713856
    Company Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Labeler DUNS
    868230876
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-09
    Public Version
    1
    Public Version Date
    2026-01-19
    Public Version Status
    New
    Public Device Record Key
    0174174e-66e1-47bd-b9fc-9f70b6179348

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JAK System, x-ray, tomography, computed

    GMDN Terms

    Code Name
    45143 PET/CT system

    Identifiers

    Type ID
    Primary 04068151048056

    Customer Contacts

    Phone
    +1(800)888-7436
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K251561 000