BEUDAMED
    FDA Registration Active 🇺🇸 United States

    475.243S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    27
    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
    K972516

    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
    Nail, Fixation, Bone JDS

    Proprietary Names

    475.243S 475.250S 47583S 47588S 47587S 47584S 47550S 475.245S 47543S 475.247S 47549S 47585S 475.249S 47591S 47582S 47546S 475.246S 47544S 47586S 47593S 47548S 47542S 475.242S 47545S 47547S 475.248S 475.244S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)