BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TheraSphere™

    DI: 00191506025625 · Model: M00139557USKit0 · BOSTON SCIENTIFIC CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    TheraSphere™
    Primary DI
    00191506025625
    Version / Model
    M00139557USKit0
    Catalog Number
    M00139557USKit0
    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
    acefa9dc-d676-498d-b066-2aac0f45cd5c

    Device Description

    Administration Accessory Kit

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KPY Shield, protective, personnel

    GMDN Terms

    Code Name
    61710 Manual-afterloading brachytherapy system storage container

    Identifiers

    Type ID
    Primary 00191506025625