BEUDAMED
    FDA Registration Active 🇺🇸 United States

    02.226.236S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    45
    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
    K021556

    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

    Proprietary Names

    02.226.236S 02.226.322S 02.226.215S 02.226.229S 02.226.227S 02.226.325S 02.226.223S 02.226.332S 02.226.326S 02.226.328S 02.226.234S 02.226.327S 02.226.212S 02.226.214S 02.226.219S 02.226.330S 02.226.329S 02.226.225S 02.226.228S 02.226.340S 02.226.240S 02.226.224S 02.226.320S 02.226.324S 02.226.238S 02.226.209S 02.226.216S 02.226.338S 02.226.221S 02.226.319S 02.226.318S 02.226.323S 02.226.211S 02.226.226S 02.226.213S 02.226.334S 02.226.217S 02.226.232S 02.226.210S 02.226.336S 02.226.230S 02.226.222S 02.226.220S 02.226.218S 02.226.321S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)