BEUDAMED
    FDA Registration Active 🇺🇸 United States

    241.305S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029275
    FEI Number
    1000306431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    344 Bonnie Cir
    City
    Corona
    State
    CA
    ZIP
    92878
    Country
    US

    Regulatory Submissions

    510(k) Number
    K033995

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    241.305S 241.283S 241.287S 241.276S 241.289S 241.286S 241.304S 241.277S 241.267S 241.300S 241.265S 241.262S 241.279S 241.303S 241.284S 241.274S 241.301S 241.302S 241.269S 241.266S 241.288S 241.278S 241.282S 241.275S 241.285S 241.268S 241.263S 241.264S 241.273S 241.272S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)