BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Glenoid Reconstruction System

    DI: 07630345710499 · Model: 04.01.0320 · Medacta International SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Glenoid Reconstruction System
    Primary DI
    07630345710499
    Version / Model
    04.01.0320
    Company Name
    Medacta International SA
    Labeler DUNS
    488227125
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-28
    Public Version
    2
    Public Version Date
    2024-02-19
    Public Version Status
    Update
    Public Device Record Key
    4fa248ca-9390-42c7-bb03-719c2d1c1326

    Device Description

    GRS central screw - L15

    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

    GMDN Terms

    Code Name
    48094 Shoulder prosthesis screw

    Identifiers

    Type ID
    Primary 07630345710499

    Premarket Submissions

    Submission Number Supplement Number
    K213459 000