BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    InsightRT CDS

    DI: B244IRT1000 · Model: IRT100 · SIRIS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    InsightRT CDS
    Primary DI
    B244IRT1000
    Version / Model
    IRT100
    Catalog Number
    IRT100
    Company Name
    SIRIS MEDICAL, INC.
    Labeler DUNS
    079081812
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-08
    Public Version
    5
    Public Version Date
    2021-01-18
    Public Version Status
    Update
    Public Device Record Key
    93df8ffa-7c8f-4e35-b6fb-fe4060107b9a

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MUJ System,Planning,Radiation Therapy Treatment

    GMDN Terms

    Code Name
    40887 Radiation therapy software

    Identifiers

    Type ID
    Primary B244IRT1000

    Customer Contacts

    Phone
    6503945161
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K151560 000