BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SAVI Prep Device

    Reg #: 2032338 · FEI: 3003295907 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Merit Medical Systems, Inc.
    Registration Number
    2032338
    FEI Number
    3003295907
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 JOURNEY, SUITE 125
    City
    ALISO VIEJO
    State
    CA
    ZIP
    92656
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101411

    Owner / Operator

    Firm Name
    Merit Medical Systems, Inc.
    Operator Number
    1721504
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    Postal Code
    84095
    Country
    US

    Products

    Device Name Product Code
    System, Applicator, Radionuclide, Remote-Controlled JAQ

    Proprietary Names

    SAVI Prep Device SAVI Spacer

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility