BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Omni Stable AF

    DI: 00842078124161 · Model: 155-11112 · EXTREMITY MEDICAL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Omni Stable AF
    Primary DI
    00842078124161
    Version / Model
    155-11112
    Company Name
    EXTREMITY MEDICAL, LLC
    Labeler DUNS
    832720358
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-09
    Public Version
    2
    Public Version Date
    2024-02-19
    Public Version Status
    Update
    Public Device Record Key
    6fbb03da-4394-4dcb-8426-4553f430cb69

    Device Description

    Lateral Fibula Plate, 17 Holes (11 Proximal), Right

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HRS Plate, Fixation, Bone

    GMDN Terms

    Code Name
    61573 Orthopaedic fixation plate, non-bioabsorbable, non-sterile

    Identifiers

    Type ID
    Primary 00842078124161

    Premarket Submissions

    Submission Number Supplement Number
    K212297 000