BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DUOLITH SD1 T-Top

    Reg #: 1061158 · FEI: 1000511585 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STORZ MEDICAL AMERICA, INC.
    Registration Number
    1061158
    FEI Number
    1000511585
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1000 COBB PLACE BLVD, BUILDING 400, SUITE 450
    City
    Kennesaw
    State
    GA
    ZIP
    30144
    Country
    US

    Regulatory Submissions

    PMA Number
    P080028

    Owner / Operator

    Firm Name
    STORZ MEDICAL AG
    Operator Number
    9028780
    Address
    LOHSTAMPFESTRASSE 8, --
    City
    TAEGERWILEN
    State
    Thurgau
    Postal Code
    CH-8274
    Country
    CH
    Correspondent
    JOERG - FREIDINGER

    Products

    Device Name Product Code
    Generator, Shock-Wave, For Pain Relief NBN

    Proprietary Names

    DUOLITH SD1 T-Top CHATTANOOGA Intelect F-SW USA DUOLITH SD1 TOWER

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198