BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    InnoFine

    DI: 06971554722974 · Model: JSP-010 · 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
    06971554722974
    Version / Model
    JSP-010
    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
    2
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    99e775c8-826b-4a51-853b-3e62461ec09a

    Device Description

    Reusable Needle Guides for use with Wisonic L15-4B, L15-4NB Ultrasound Transducers and BARD Needle Guide 900013B01(21G).

    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
    No
    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
    High-level Disinfectant

    Product Codes

    Code Name
    OIJ Biopsy Needle Guide Kit

    GMDN Terms

    Code Name
    60734 Needle guide, reusable

    Identifiers

    Type ID
    Primary 06971554722974