BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BIONIX RADIATION THERAPY

    DI: 08177400245002 · Model: SBRT-4500 · Bionix Radiation Therapy, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BIONIX RADIATION THERAPY
    Primary DI
    08177400245002
    Version / Model
    SBRT-4500
    Catalog Number
    SBRT-4500
    Company Name
    Bionix Radiation Therapy, LLC
    Labeler DUNS
    080397923
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-27
    Public Version
    4
    Public Version Date
    2023-07-10
    Public Version Status
    Update
    Public Device Record Key
    f20e5897-63aa-467a-b792-654005a4378d
    Distribution End Date
    2017-02-01

    Device Description

    OMNI V SBRT POSITIONING SYSTEM

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IYE Accelerator, linear, medical

    GMDN Terms

    Code Name
    61110 Radiation therapy treatment planning positioning kit

    Identifiers

    Type ID
    Primary 08177400245002

    Customer Contacts

    Phone
    +1(800)624-6649
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K100691 000