BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Silicone Foley Tray: 6140

    Reg #: 2011171 · FEI: 2011171 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    2011171
    FEI Number
    2011171
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4900 Gifford Ave
    City
    Los Angeles
    State
    CA
    ZIP
    90058
    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)