BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GFS II Standard, Large and Mini

    DI: 00816342021807 · Model: 10713 · PARCUS MEDICAL LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    GFS II Standard, Large and Mini
    Primary DI
    00816342021807
    Version / Model
    10713
    Company Name
    PARCUS MEDICAL LLC
    Labeler DUNS
    859961950
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-26
    Public Version
    2
    Public Version Date
    2025-09-17
    Public Version Status
    Update
    Public Device Record Key
    29121833-7f55-4e76-ab89-a792b5f48f47

    Device Description

    GFS MINI 12

    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
    MR Conditional
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

    GMDN Terms

    Code Name
    45062 Tendon/ligament bone anchor, non-bioabsorbable

    Identifiers

    Type ID
    Primary 00816342021807