BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TheraSphere™

    DI: 00191506025595 · Model: M00139554BBR0 · BOSTON SCIENTIFIC CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    TheraSphere™
    Primary DI
    00191506025595
    Version / Model
    M00139554BBR0
    Catalog Number
    M00139554BBR0
    Company Name
    BOSTON SCIENTIFIC CORPORATION
    Labeler DUNS
    021717889
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-01
    Public Version
    1
    Public Version Date
    2026-03-09
    Public Version Status
    New
    Public Device Record Key
    0f3d5ecc-9599-411a-8565-d6ce4763718b

    Device Description

    Administration set

    Device Characteristics

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IWJ System, applicator, radionuclide, manual

    GMDN Terms

    Code Name
    61711 Manual-afterloading brachytherapy system source delivery procedure kit

    Identifiers

    Type ID
    Package 00191506025601
    Primary 00191506025595