BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Wireless Probe Type Ultrasound Scanner

    DI: 06970672750029 · Model: UProbe · Guangzhou Sonostar Technologies Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Wireless Probe Type Ultrasound Scanner
    Primary DI
    06970672750029
    Version / Model
    UProbe
    Company Name
    Guangzhou Sonostar Technologies Co., Ltd.
    Labeler DUNS
    543263098
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-01
    Public Version
    2
    Public Version Date
    2021-05-03
    Public Version Status
    Update
    Public Device Record Key
    e865f65e-fdd2-456c-9e67-8b4f472c198a

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Hydrogen Peroxide", "High-level Disinfectant"]

    Product Codes

    Code Name
    ITX Transducer, Ultrasonic, Diagnostic
    IYO System, Imaging, Pulsed Echo, Ultrasonic

    GMDN Terms

    Code Name
    60924 Hand-held ultrasound imaging system, body-surface

    Identifiers

    Type ID
    Primary 06970672750029

    Premarket Submissions

    Submission Number Supplement Number
    K172750 000