BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RayStation

    DI: 07350002010570 · Model: 11B SPT1 · Raysearch Laboratories AB (Publ)
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    RayStation
    Primary DI
    07350002010570
    Version / Model
    11B SPT1
    Company Name
    Raysearch Laboratories AB (Publ)
    Labeler DUNS
    355977901
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-12
    Public Version
    1
    Public Version Date
    2023-05-22
    Public Version Status
    New
    Public Device Record Key
    5be64754-5363-4c28-b0ad-a502f70c573a

    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
    No
    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
    MUJ System, Planning, Radiation Therapy Treatment

    GMDN Terms

    Code Name
    40887 Radiation therapy software

    Identifiers

    Type ID
    Primary 07350002010570

    Premarket Submissions

    Submission Number Supplement Number
    K220141 000