BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Locking Proximal Femur Plate System (LPF)

    DI: 00840194462945 · Model: 00-0907-1484 · ORTHOPEDIATRICS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Locking Proximal Femur Plate System (LPF)
    Primary DI
    00840194462945
    Version / Model
    00-0907-1484
    Catalog Number
    00-0907-1484
    Company Name
    ORTHOPEDIATRICS CORP.
    Labeler DUNS
    796416191
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-27
    Public Version
    1
    Public Version Date
    2023-11-06
    Public Version Status
    New
    Public Device Record Key
    1e94d0f7-109a-4add-bf75-be2debb33843

    Device Description

    130° X 4.5MM VALGUS PLATES,14MM OFFSET, 4 HOLE

    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
    46647 Orthopaedic fixation plate, non-bioabsorbable

    Identifiers

    Type ID
    Primary 00840194462945

    Premarket Submissions

    Submission Number Supplement Number
    K111086 000