BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dosimetry Check

    DI: B229DC051 · Model: 5 · MATH RESOLUTIONS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Dosimetry Check
    Primary DI
    B229DC051
    Version / Model
    5
    Company Name
    MATH RESOLUTIONS, LLC
    Labeler DUNS
    021888258
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-08
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    6f596e0c-e5f1-4985-9646-4fb550e52913

    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
    IYE Accelerator, Linear, Medical

    GMDN Terms

    Code Name
    40887 Radiation therapy software

    Identifiers

    Type ID
    Primary B229DC051

    Premarket Submissions

    Submission Number Supplement Number
    K010225 000
    K101503 000
    K132605 000
    K162577 000