BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ulthera System Control Unit PRIME

    DI: 00840763101145 · Model: UC-1 Control Unit (PRIME) Rev. A · Ulthera, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Ulthera System Control Unit PRIME
    Primary DI
    00840763101145
    Version / Model
    UC-1 Control Unit (PRIME) Rev. A
    Company Name
    Ulthera, Inc.
    Labeler DUNS
    010981554
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-10
    Public Version
    2
    Public Version Date
    2024-05-09
    Public Version Status
    Update
    Public Device Record Key
    65b8f012-f8da-41d7-977f-cba699342860

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
    IYO System, Imaging, Pulsed Echo, Ultrasonic

    GMDN Terms

    Code Name
    40777 Ultrasound hyperthermia system transducer, extracorporeal

    Identifiers

    Type ID
    Primary 00840763101145