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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Humelock II Cementless Shoulder System

    DI: 03701037302804 · Model: 106-2000 · 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
    03701037302804
    Version / Model
    106-2000
    Catalog Number
    106-2000
    Company Name
    FX SOLUTIONS
    Labeler DUNS
    263076196
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-09
    Public Version
    5
    Public Version Date
    2024-02-19
    Public Version Status
    Update
    Public Device Record Key
    5c34aa76-32d6-40a0-b14c-b1a86f4c387b

    Device Description

    PROTECTOR + SCREW TA6V

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

    GMDN Terms

    Code Name
    48094 Shoulder prosthesis screw

    Identifiers

    Type ID
    Primary 03701037302804

    Customer Contacts

    Phone
    +33474553397
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K130759 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store away from light and sunlight Store away from moisture