BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bayer1675 (GR) - [Spectris Solaris EP MR Injector System] Disposable MRI Kit for 65/115 MR Injector System

    Reg #: 1526711 · FEI: 1526711 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC
    Registration Number
    1526711
    FEI Number
    1526711
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4405 MARKETING PLACE
    City
    GROVEPORT
    State
    OH
    ZIP
    43125
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042784

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Injector And Syringe, Angiographic DXT

    Proprietary Names

    Bayer1675 (GR) - [Spectris Solaris EP MR Injector System] Disposable MRI Kit for 65/115 MR Injector System Bayer1675 (GR) - Disposable MRI Kit for 65/115 MR Injector System Bayer1675 (GR) - Saline Syringe & Tubing for MR Injector System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)