BEUDAMED
    FDA Registration Active 🇺🇸 United States

    02.10023S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    22
    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
    K071264

    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

    02.10023S 447.706S 04.10023S 447.704S 247.706S 447.702S 04.10021S 447.710S 02.10021S 04.10022S 449.690S 02.10020S 247.711S 04.10020S 449.691S 249.690S 249.691S 247.702S 247.704S 02.10022S 247.710S 447.711S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)