BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Fibrant Instrument Kit

    DI: M896IBK00010 · Model: IB-K-0001 · Arteriocyte Medical Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Fibrant Instrument Kit
    Primary DI
    M896IBK00010
    Version / Model
    IB-K-0001
    Company Name
    Arteriocyte Medical Systems, Inc.
    Labeler DUNS
    809012870
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-19
    Public Version
    2
    Public Version Date
    2026-04-13
    Public Version Status
    Update
    Public Device Record Key
    666900c4-3f1f-493f-b0cf-ecff64fe37c2

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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
    FSM Tray, Surgical, Instrument

    GMDN Terms

    Code Name
    33961 General surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary M896IBK00010