BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spring Coil Guidewire

    Reg #: 3008988055 · FEI: 3008988055 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HERAEUS MEDICAL COMPONENTS, LLC
    Registration Number
    3008988055
    FEI Number
    3008988055
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5030 Centerville Road
    City
    Saint Paul
    State
    MN
    ZIP
    55127
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143135

    Owner / Operator

    Firm Name
    Heraeus Medical Components, LLC
    Operator Number
    9045241
    Address
    5030 Centerville Road
    City
    Saint Paul
    State
    MN
    Postal Code
    55127
    Country
    US
    Correspondent
    Timothy Desaulniers

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    Spring Coil Guidewire

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198