BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TEE Articulated Arm

    DI: 06971355420840 · Model: PHA-10 · SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    TEE Articulated Arm
    Primary DI
    06971355420840
    Version / Model
    PHA-10
    Company Name
    SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
    Labeler DUNS
    543063066
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-27
    Public Version
    1
    Public Version Date
    2022-02-04
    Public Version Status
    New
    Public Device Record Key
    a695b656-de46-47c6-966c-718969e05546

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

    GMDN Terms

    Code Name
    61952 Frame/rail/pole device holder

    Identifiers

    Type ID
    Primary 06971355420840

    Premarket Submissions

    Submission Number Supplement Number
    K210154 000