BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDRAD® Spectris Solaris EP MR Injection System

    Reg #: 3004056159 · FEI: 3004056159 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Bayer Medical Care Inc.
    Registration Number
    3004056159
    FEI Number
    3004056159
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    625 Alpha Dr
    City
    Pittsburgh
    State
    PA
    ZIP
    15238
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042784

    Owner / Operator

    Firm Name
    Bayer Medical Care Inc.
    Operator Number
    2520313
    Address
    1 Bayer Drive
    City
    Indianola
    State
    PA
    Postal Code
    15051
    Country
    US
    Correspondent
    Troy A Jack

    Products

    Device Name Product Code
    Injector And Syringe, Angiographic DXT

    Proprietary Names

    MEDRAD® Spectris Solaris EP MR Injection System MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve MEDRAD® Disposable MRI Kit for 65/115 MR Injector System MEDRAD® Saline Syringe & Tubing for MR Injector System

    Establishment Types

    Manufacture Medical Device