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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Proteus 235

    DI: 05404013820504 · Model: Proteus ONE · Ion Beam Applications SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Proteus 235
    Primary DI
    05404013820504
    Version / Model
    Proteus ONE
    Company Name
    Ion Beam Applications SA
    Labeler DUNS
    372078154
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-22
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    5713a926-3067-459e-af11-000040ac577d

    Device Description

    IBA Proton Therapy System – Proteus 235

    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
    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
    LHN System, Radiation Therapy, Charged-Particle, Medical

    GMDN Terms

    Code Name
    47069 Proton therapy system

    Identifiers

    Type ID
    Primary 05404013820504