BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Radifocus Introducer II with R/O Marker

    Reg #: 1118880 · FEI: 1118880 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    TERUMO MEDICAL CORP.
    Registration Number
    1118880
    FEI Number
    1118880
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    950 ELKTON BLVD.
    City
    ELKTON
    State
    MD
    ZIP
    21921
    Country
    US

    Regulatory Submissions

    510(k) Number
    K003424

    Owner / Operator

    Firm Name
    TERUMO MEDICAL CORP.
    Operator Number
    9003933
    Address
    265 Davidson Avenue, Ste. 320
    City
    Somerset
    State
    NJ
    Postal Code
    08873
    Country
    US

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    Radifocus Introducer II with R/O Marker Pinnacle R/O II

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device