BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EZ-TRAX™

    DI: 00850025473859 · Model: 144 BRACKETINSERT-S80-2.0-1.550-STDRD-12MM · K1 MEDICAL TECHNOLOGIES, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EZ-TRAX™
    Primary DI
    00850025473859
    Version / Model
    144 BRACKETINSERT-S80-2.0-1.550-STDRD-12MM
    Catalog Number
    144 BRACKETINSERT-S80-2.0-1.550-STDRD-12MM
    Company Name
    K1 MEDICAL TECHNOLOGIES, LLC
    Labeler DUNS
    080448429
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-02
    Public Version
    2
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    ef95626d-baf4-4f20-b146-125a5aec5e50

    Device Description

    BRACKET INSERT SILICONE 80 (H) 2.0 (W) 1.550 STANDARD ROUND DIA. 12MM

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

    Sterilization

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

    Product Codes

    Code Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary 00850025473859