BEUDAMED
    FDA Registration Active 🇺🇸 United States

    02.12324S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    36
    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
    K082625

    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

    02.12324S 04.12326S 04.12332S 04.12320S 02.12331S 04.12323S 02.12329S 04.12327S 04.12342S 04.12330S 02.12330S 04.12329S 04.12322S 02.12320S 02.12322S 02.12321S 02.12332S 02.12343S 04.12324S 02.12325S 04.12340S 04.12321S 04.12341S 04.12331S 04.12333S 02.12333S 02.12326S 02.12323S 04.12328S 04.12325S 02.12327S 02.12341S 02.12328S 02.12342S 04.12343S 02.12340S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)