BEUDAMED
    FDA Registration Active 🇺🇸 United States

    458.62S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    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
    K933518

    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

    458.62S 462.960S 458.56S 458.54S 458.50S 462.965S 458.20S 458.42S 458.24S 458.64S 458.36S 462.950S 458.38S 458.60S 458.18S 458.52S 458.32S 462.955S 458.48S 458.26S 458.44S 458.46S 458.40S 458.30S 458.58S 458.22S 458.34S 458.28S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)