BEUDAMED
    FDA Registration Active 🇺🇸 United States

    0405.422S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    27
    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
    K103002

    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
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    0405.422S 0405.438S 0405.448S 0405.414S 0405.410S 0405.412S 0405.420S 0405.456S 0405.426S 0405.432S 0405.458S 0405.434S 0405.452S 0405.446S 0405.428S 0405.424S 0405.454S 0405.444S 0405.440S 0405.418S 0405.450S 0405.408S 0405.416S 0405.442S 0405.460S 0405.436S 0405.430S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)