BEUDAMED
    FDA Registration Active 🇺🇸 United States

    02.11005S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    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
    K070946

    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

    02.11005S 04.110.113S 04.110.109S 02.110.105S 04.110.105S 02.11007S 04.11009S 02.110.115S 04.11005S 02.11013S 02.110.107S 02.110.109S 04.11015S 02.11011S 04.110.115S 04.110.111S 02.11009S 04.11007S 04.11013S 02.110.113S 02.11015S 04.110.107S 04.11011S 02.110.111S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)