BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FX V135

    DI: 03701037321072 · Model: 911-2111 · FX SOLUTIONS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FX V135
    Primary DI
    03701037321072
    Version / Model
    911-2111
    Company Name
    FX SOLUTIONS
    Labeler DUNS
    263076196
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-02-20
    Public Version
    1
    Public Version Date
    2025-02-28
    Public Version Status
    New
    Public Device Record Key
    6eea6eed-0ac5-4f24-a2cc-3357f7cabab1

    Device Description

    XS GLENOID K-WIRE GUIDE +TEMPLATE W/10° POSTERIOR TILT

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

    GMDN Terms

    Code Name
    44054 Orthopaedic surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 03701037321072