BEUDAMED
    FDA Registration Active 🇺🇸 United States

    24002S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    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
    K983787

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    24002S 24107S 24110S 24109S 24112S 24011S 24115S 24004S 24003S 24116S 24010S 24006S 24012S 24007S 24104S 24113S 24111S 24105S 24114S 24014S 24019S 24005S 24108S 24013S 24106S 24015S 24008S 24009S 24117S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)