BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SonoBook Series Diagnostic Ultrasound Systems

    DI: 06945121411172 · Model: SonoBook 9 · CHISON Medical Technologies Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    28
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SonoBook Series Diagnostic Ultrasound Systems
    Primary DI
    06945121411172
    Version / Model
    SonoBook 9
    Company Name
    CHISON Medical Technologies Co., Ltd.
    Labeler DUNS
    544914187
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-02
    Public Version
    5
    Public Version Date
    2022-09-05
    Public Version Status
    Update
    Public Device Record Key
    fcaa5706-41db-49e6-8b66-7dc02a1b43fa

    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic
    IYO System, Imaging, Pulsed Echo, Ultrasonic

    GMDN Terms

    Code Name
    40761 General-purpose ultrasound imaging system

    Identifiers

    Type ID
    Primary 06945121411172
    Package 06945121411981
    Package 06945121411974
    Package 06945121411967
    Package 06945121411837
    Package 06945121411820
    Package 06945121411813
    Package 06945121411806
    Package 06945121411790
    Package 06945121411783
    Package 06945121411776
    Package 06945121411769
    Package 06945121411752
    Package 06945121411745
    Package 06945121411738
    Package 06945121411721
    Package 06945121411844
    Package 06945121411851
    Package 06945121411868
    Package 06945121411875
    Package 06945121411882
    Package 06945121411899
    Package 06945121411905
    Package 06945121411912
    Package 06945121411929
    Package 06945121411936
    Package 06945121411943
    Package 06945121411950

    Premarket Submissions

    Submission Number Supplement Number
    K170374 000