BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    InnoFine

    DI: 06971554720017 · Model: JEM-028 · JingFang Precision Medical Device(Shenzhen) Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    InnoFine
    Primary DI
    06971554720017
    Version / Model
    JEM-028
    Company Name
    JingFang Precision Medical Device(Shenzhen) Co., Ltd.
    Labeler DUNS
    544571975
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-04
    Public Version
    3
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    02808c45-6563-4504-a60e-a6dcfbf640b5

    Device Description

    Reusable Needle Guides for use with Mindray 65EC10EA, 65EC10EB, 6CV1(s), 6CV1P, CB10-4(s), CB10-4P, CB10-4E, CB10-4A, V10-4(s), V10-4B(s), V10-4BP, V11-3Ws, V11-3(E), V11-3B(E), V11-3W(E), E9-3, V11-3HE, V11-3HU; Wisonic EV10-4, EV11-3-H Ultrasound Transducers

    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
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    OIJ Biopsy Needle Guide Kit

    GMDN Terms

    Code Name
    60734 Needle guide, reusable

    Identifiers

    Type ID
    Primary 06971554720017