BEUDAMED
    FDA Registration Active 🇺🇸 United States

    42105S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    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
    K033121

    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

    42105S 44651S 44635S 44619S 42120S 42112S 42104S 42116S 44653S 42115S 44652S 44614S 44615S 42108S 42107S 42117S 42114S 44636S 44650S 44618S 42109S 42111S 42119S 44633S 44634S 42113S 44655S 44654S 44617S 42118S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)