BEUDAMED
    FDA Registration Active 🇺🇸 United States

    464.48S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    40
    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
    K923580

    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

    464.48S 467.44S 467.30S 466.46S 466.34S 465.42S 466.44S 465.48S 466.32S 467.32S 465.44S 466.42S 467.40S 467.38S 467.46S 466.48S 464.36S 466.38S 465.46S 465.32S 467.36S 464.32S 465.36S 464.38S 465.40S 466.40S 466.30S 466.36S 467.48S 464.42S 465.30S 464.30S 465.34S 464.34S 467.34S 464.46S 465.38S 464.44S 467.42S 464.40S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)