BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TriLeap Lower Extremity Anatomic Plating System

    DI: 00810112594690 · Model: 3.5 mm Ti Cortex Screw Length 38 mm, Dark Purple · CROSSROADS EXTREMITY SYSTEMS
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TriLeap Lower Extremity Anatomic Plating System
    Primary DI
    00810112594690
    Version / Model
    3.5 mm Ti Cortex Screw Length 38 mm, Dark Purple
    Catalog Number
    04.909.038
    Company Name
    CROSSROADS EXTREMITY SYSTEMS
    Labeler DUNS
    058864308
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-22
    Public Version
    2
    Public Version Date
    2024-03-01
    Public Version Status
    Update
    Public Device Record Key
    2ebe9bd7-5915-4af0-a7c9-7fba15bdeb7f

    Device Description

    3.5 mm Ti Cortex Screw Length 38 mm, Dark Purple

    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
    HWC Screw, Fixation, Bone

    GMDN Terms

    Code Name
    66947 Orthopaedic bone screw (non-sliding)

    Identifiers

    Type ID
    Primary 00810112594690

    Premarket Submissions

    Submission Number Supplement Number
    K230591 000