BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mazor X System

    DI: 07290115751895 · Model: TPL0059-10 · MAZOR ROBOTICS LTD
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mazor X System
    Primary DI
    07290115751895
    Version / Model
    TPL0059-10
    Company Name
    MAZOR ROBOTICS LTD
    Labeler DUNS
    532681590
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-04-27
    Public Version
    3
    Public Version Date
    2025-11-28
    Public Version Status
    Update
    Public Device Record Key
    b0c8b809-cd26-44a5-a638-003618ef7426

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OLO Orthopedic Stereotaxic Instrument
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    45199 Multi-purpose stereotactic surgery system

    Identifiers

    Type ID
    Primary 07290115751895

    Premarket Submissions

    Submission Number Supplement Number
    K230064 000
    K251316 000