BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TEMA Elbow

    DI: 08033390231442 · Model: 9015.50.176 · LIMACORPORATE SPA
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TEMA Elbow
    Primary DI
    08033390231442
    Version / Model
    9015.50.176
    Catalog Number
    9015.50.176
    Company Name
    LIMACORPORATE SPA
    Labeler DUNS
    432066322
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-18
    Public Version
    2
    Public Version Date
    2024-01-08
    Public Version Status
    Update
    Public Device Record Key
    00f99ebc-a7c1-4a95-b561-21b27957e739

    Device Description

    TEMA Elbow - Taper Breaker for Articulation Assembly Stem

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

    Sterilization

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

    Product Codes

    Code Name
    JDB Prosthesis, Elbow, Semi-Constrained, Cemented
    JDC Prosthesis, Elbow, Constrained, Cemented

    GMDN Terms

    Code Name
    12696 Orthopaedic implant inserter/extractor, reusable

    Identifiers

    Type ID
    Primary 08033390231442