BEUDAMED
    FDA Registration Active 🇺🇸 United States

    352.200S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    20
    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
    K013527

    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
    Reamer HTO
    Arthroscope HRX

    Proprietary Names

    352.200S 352.258S 352.205S 352.204S 352.252S 352.254S 352.257S 352.207S 352.255S 352.209S 352.211S 314.745S 352.251S 352.256S 352.202S 314.746S 352.250S 352.253S 352.259S 351.718S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)