BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TheRay Collared and Collarless Femoral Stem

    DI: 00816127026638 · Model: 12-80-0013 · NEXTSTEP ARTHROPEDIX, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TheRay Collared and Collarless Femoral Stem
    Primary DI
    00816127026638
    Version / Model
    12-80-0013
    Company Name
    NEXTSTEP ARTHROPEDIX, LLC
    Labeler DUNS
    060211165
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-04
    Public Version
    1
    Public Version Date
    2024-12-12
    Public Version Status
    New
    Public Device Record Key
    e306b98f-58a7-4325-a6d9-f7bf728fdae9

    Device Description

    Starter Broach, Collared 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
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    36167 Orthopaedic broach

    Identifiers

    Type ID
    Primary 00816127026638