BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Acuity iX Radiation Therapy Simulation System

    DI: 00856545006003 · Model: 15.0 · VARIAN MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Acuity iX Radiation Therapy Simulation System
    Primary DI
    00856545006003
    Version / Model
    15.0
    Catalog Number
    TM60010004
    Company Name
    VARIAN MEDICAL SYSTEMS, INC.
    Labeler DUNS
    009120817
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-20
    Public Version
    1
    Public Version Date
    2020-09-28
    Public Version Status
    New
    Public Device Record Key
    e617965b-d7fa-459e-a397-c1d9aaf1e312

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KPQ System, simulation, radiation therapy

    GMDN Terms

    Code Name
    35294 Radiation therapy simulation system

    Identifiers

    Type ID
    Primary 00856545006003

    Premarket Submissions

    Submission Number Supplement Number
    K033339 000