BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    XR-MX/1000

    DI: 07630039101046 · Model: FD43 (80 kW) · Storz Medical AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    XR-MX/1000
    Primary DI
    07630039101046
    Version / Model
    FD43 (80 kW)
    Catalog Number
    29255
    Company Name
    Storz Medical AG
    Labeler DUNS
    481967776
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-04-08
    Public Version
    1
    Public Version Date
    2021-04-16
    Public Version Status
    New
    Public Device Record Key
    6be43fe0-67f1-453c-a998-69c6db6f2165

    Device Description

    The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimally invasive urological surgery). The system may be used for urological treatment, planning and diagnostic procedures.

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    GMDN Terms

    Code Name
    37633 Stationary uro-gynaecological fluoroscopic x-ray system, digital

    Identifiers

    Type ID
    Primary 07630039101046

    Premarket Submissions

    Submission Number Supplement Number
    K200965 000