BEUDAMED
    FDA Registration Active 🇺🇸 United States

    421.543S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    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
    K033160

    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, Bone JEY

    Proprietary Names

    421.543S 421.544S 421.547S 421.532S 421.539S 421.538S 421.533S 421.531S 421.540S 421.546S 421.536S 421.545S 421.535S 421.541S 421.542S 421.537S 421.534S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)