BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TRUELOK SYSTEM

    DI: 18033509853715 · Model: 1 · ORTHOFIX SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TRUELOK SYSTEM
    Primary DI
    18033509853715
    Version / Model
    1
    Catalog Number
    54-1135B
    Company Name
    ORTHOFIX SRL
    Labeler DUNS
    438793622
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-04-24
    Public Version
    7
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    958175f2-4e2a-4c36-98ed-33c8be31f7c1

    Device Description

    TRUE/LOK TRAY BASE, FIXATION ELEMENTS

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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
    LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary 18033509853715

    Customer Contacts

    Phone
    +0390456719000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K941048 000