BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Humeral Cup Stability

    DI: 03701037310496 · Model: 314-0903 · FX SOLUTIONS
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Humeral Cup Stability
    Primary DI
    03701037310496
    Version / Model
    314-0903
    Catalog Number
    314-0903
    Company Name
    FX SOLUTIONS
    Labeler DUNS
    263076196
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-20
    Public Version
    2
    Public Version Date
    2021-10-08
    Public Version Status
    Update
    Public Device Record Key
    d51194fc-b946-4d1a-b37b-175779ba59d7

    Device Description

    HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +3

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
    KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
    PHX Shoulder Prosthesis, Reverse Configuration

    GMDN Terms

    Code Name
    48092 Polyethylene reverse shoulder prosthesis cup

    Identifiers

    Type ID
    Primary 03701037310496