BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LATERALIZED AND AUGMENTED BASEPLATE

    DI: 03701037316801 · Model: 105-0029 · FX SOLUTIONS
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LATERALIZED AND AUGMENTED BASEPLATE
    Primary DI
    03701037316801
    Version / Model
    105-0029
    Company Name
    FX SOLUTIONS
    Labeler DUNS
    263076196
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-15
    Public Version
    2
    Public Version Date
    2021-10-07
    Public Version Status
    Update
    Public Device Record Key
    161abbd7-1e0d-4fd3-a48f-24e4d9ac0b26

    Device Description

    TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW Ti/HA Ø24mm, +3mm LATERALIZED

    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
    PHX Shoulder Prosthesis, Reverse Configuration
    HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

    GMDN Terms

    Code Name
    36259 Shoulder glenoid fossa prosthesis, prefabricated

    Identifiers

    Type ID
    Primary 03701037316801