BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Silicone Foley Tray: 6140

    Reg #: 2029015 · FEI: 1000160458 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029015
    FEI Number
    1000160458
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    687 S Wanamaker Ave
    City
    Ontario
    State
    CA
    ZIP
    91761
    Country
    US

    Regulatory Submissions

    510(k) Number
    K024010

    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
    Catheter, Retention Type, Balloon EZL
    Catheter, Urological KOD

    Proprietary Names

    Silicone Foley Tray: 6140 Silicone Foley Tray: 6210 Silicone Foley Tray: 6148MF Silicone Foley Tray: 6146LL Silicone Foley Tray: 6146ICLL Silicone Foley Tray: 6950 Silicone Foley Tray: 8887600776 Silicone Foley Tray: 6148LL Silicone Foley Tray: 7008ICLL Silicone Foley Tray: 8887600784 Silicone Foley Tray: 8949 Foley Insertion Tray: 2118IC Silicone Foley Tray: 7006ICLL Silicone Foley Tray: 6947LF Silicone Foley Tray: 6070 Silicone Foley Tray: 6144ICLL Silicone Foley Tray: 6144LL Silicone Foley Tray: 6146MF Silicone Foley Tray: 7004ICLL Silicone Foley Tray: 8950 Silicone Foley Tray: 6148ICLL Foley Insertion Tray: 2166IC Silicone Foley Tray: 6144MF Dover Silver Coated 100% Silicone Foley Catheter

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)