BEUDAMED
    FDA Registration Active 🇺🇸 United States

    437.143S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    44
    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
    K974537

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    437.143S 43743S 437.124S 237.143S 437.146S 43744S 23786S 43786S 23763S 237.144S 437.103S 23783S 237.103S 437.104S 43754S 237.124S 437.106S 23754S 23753S 237.126S 43783S 43785S 237.105S 43764S 23764S 23784S 237.106S 237.146S 43784S 437.105S 437.145S 437.126S 237.145S 23744S 23743S 437.144S 437.123S 237.104S 43763S 23785S 237.123S 437.125S 237.125S 43753S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)