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    FDA UDI In Commercial Distribution 🇺🇸 United States

    JARVIS Glenoid Rerverse Shoulder Prosthesis

    DI: 03661489719738 · Model: 271973 - STANDARD GLENOSPHERE D36 LAT 8 · FOURNITURES HOSPITALIERES INDUSTRIE
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    JARVIS Glenoid Rerverse Shoulder Prosthesis
    Primary DI
    03661489719738
    Version / Model
    271973 - STANDARD GLENOSPHERE D36 LAT 8
    Company Name
    FOURNITURES HOSPITALIERES INDUSTRIE
    Labeler DUNS
    261839898
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-09
    Public Version
    1
    Public Version Date
    2024-12-17
    Public Version Status
    New
    Public Device Record Key
    14483030-0c3c-43a3-a3d4-c4c021040199

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
    PHX Shoulder Prosthesis, Reverse Configuration
    KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

    GMDN Terms

    Code Name
    48093 Reverse shoulder prosthesis head

    Identifiers

    Type ID
    Primary 03661489719738

    Premarket Submissions

    Submission Number Supplement Number
    K242253 000