BEUDAMED
    FDA Registration Active 🇺🇸 United States

    474.346S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    69
    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
    K954856

    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
    Implant, Fixation Device, Spinal JDN
    Pin, Fixation, Smooth HTY

    Proprietary Names

    474.346S 474.531S 474.336S 474.341S 474.138S 474.922S 474.541S 474.342S 474.234S 474.913S 474.448S 474.431S 474.536S 47436S 47448S 474.146 474.142S 474.900S 474.348S 47431S 474.542S 47446S 474.344S 474.442S 474.432S 474.236S 474.538S 474.434S 47444S 474.910S 474.338S 47442S 474.144S 474.544S 474.248S 474.332S 474.136S 474.131S 474.444S 474.231S 474.920S 474.148S 47432S 474.921S 474.532S 474.438S 474.132S 474.134S 474.548S 474.242S 474.546S 474.146S 474.446S 474.141S 474.334S 474.436S 474.241S 47434S 474.246S 474.244S 474.911S 47438S 474.238S 474.534S 474.331S 474.232S 47441S 474.441S 474.912S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)