BEUDAMED
    FDA Registration Active 🇺🇸 United States

    426.632S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    61
    Establishment Types
    1
    Classifications
    2

    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
    K092609

    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
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    426.632S 02.161.274S 02.161.286S 02.161.214S 02.161.222S 04.161.246S 04.161.214S 02.161.250S 426.622S 426.702S 02.161.244S 426.722S 02.161.216S 04.161.218S 04.161.272S 04.161.220S 02.161.252S 04.161.248S 02.161.282S 02.161.240S 04.161.240S 02.161.280S 04.161.210S 426.762S 426.672S 02.161.270S 04.161.242S 04.161.270S 02.161.270 04.161.274S 04.161.250S 02.161.284S 02.161.272S 426.662S 02.161.210S 04.161.290S 426.642S 02.161.246S 02.161.276S 02.161.278S 426.652S 04.161.280S 426.682S 04.161.284S 02.161.288S 02.161.290S 04.161.276S 04.161.286S 02.161.242S 04.161.212S 04.161.216S 04.161.252S 04.161.244S 02.161.212S 02.161.248S 02.161.220S 04.161.222S 02.161.218S 04.161.288S 04.161.282S 04.161.278S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)