BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDRAD® Mark V ProVis Sterile Disposable Syringe 150 mL & QFT

    Reg #: 3009504230 · FEI: 3009504230 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics Radiation Technologies IN, Inc
    Registration Number
    3009504230
    FEI Number
    3009504230
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4394 East Park 30 Drive
    City
    Columbia City
    State
    IN
    ZIP
    46725
    Country
    US

    Regulatory Submissions

    510(k) Number
    K822536

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Injector And Syringe, Angiographic DXT

    Proprietary Names

    MEDRAD® Mark V ProVis Sterile Disposable Syringe 150 mL & QFT MEDRAD Mark V Provis 150mL FasTurn Sterile Disposable Syringe Kit MEDRAD Mark V Provis 200mL FasTurn Sterile Disposable Syringe Kit MEDRAD® Mark V ProVis 200 mL FasTurn Sterile Disposable Syringe & QFT

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)