BEUDAMED
    FDA Registration Active 🇺🇸 United States

    14 Fr Clear Plastic Catheter Tray

    Reg #: 3004111573 · FEI: 3004111573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3004111573
    FEI Number
    3004111573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1302 Avenue T
    City
    Grand Prairie
    State
    TX
    ZIP
    75050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K904158

    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
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM

    Proprietary Names

    14 Fr Clear Plastic Catheter Tray Catheter Free Procedure Tray 14 FR Red Rubber Cath-Forcep 14 Fr Red Rubber Catheter Tray

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)