BEUDAMED
    FDA Registration Active 🇺🇸 United States

    478.36S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    34
    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
    K932330

    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
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    478.36S 478.34S 476.25S 478.25S 478.28S 479.42S 476.30S 478.30S 476.42S 476.33S 479.38S 476.34S 476.27S 478.42S 478.31S 479.30S 478.40S 458.10S 479.28S 478.33S 476.38S 476.36S 479.33S 479.27S 479.40S 476.40S 478.27S 479.25S 479.34S 479.31S 478.38S 476.31S 476.28S 479.36S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)