BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FAST-CUT B

    DI: 08033959224441 · Model: FAST-CUT B · STERYLAB SRL
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FAST-CUT B
    Primary DI
    08033959224441
    Version / Model
    FAST-CUT B
    Catalog Number
    FSC1825B
    Company Name
    STERYLAB SRL
    Labeler DUNS
    439659574
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-02
    Public Version
    2
    Public Version Date
    2019-10-11
    Public Version Status
    Update
    Public Device Record Key
    fcd99e80-e038-4f7c-a6f2-8d10a457821a

    Device Description

    Biopsy needle for automatic gun 18G; 25cm

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FCG Biopsy Needle
    KNW Instrument, Biopsy

    GMDN Terms

    Code Name
    64327 End-cut biopsy gun needle

    Identifiers

    Type ID
    Package 18033959224448
    Primary 08033959224441

    Premarket Submissions

    Submission Number Supplement Number
    K051506 000