BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Humelock II Cementless Shoulder System

    DI: 03701037303641 · Model: 926-1019 · FX SOLUTIONS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Humelock II Cementless Shoulder System
    Primary DI
    03701037303641
    Version / Model
    926-1019
    Catalog Number
    926-1019
    Company Name
    FX SOLUTIONS
    Labeler DUNS
    263076196
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-06
    Public Version
    3
    Public Version Date
    2021-10-07
    Public Version Status
    Update
    Public Device Record Key
    77e94f95-15df-4313-8946-10836b5a23bd

    Device Description

    TRIAL OFFSET HEAD 54x21

    Device Characteristics

    Single Use
    No
    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
    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
    HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

    GMDN Terms

    Code Name
    44054 Orthopaedic surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 03701037303641