BEUDAMED
    FDA Registration Active 🇺🇸 United States

    494.783SHA

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    49
    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
    K082650

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    494.783SHA 294.43SHA 494.772SHA 294.794SHA 294.788SHA 294.67SHA 294.57SHA 494.785SHA 294.778SHA 294.793SHA 294.786SHA 03.30113S 294.44SHA 494.786SHA 494.784SHA 294.772SHA 294.798SHA 294.795SHA 294.30SHA 294.76SHA 294.777SHA 294.75SHA 294.55SHA 294.771SHA 494.782SHA 294.796SHA 294.784SHA 294.785SHA 294.779SHA 294.46SHA 294.783SHA 294.782SHA 294.53SHA 294.54SHA 294.56SHA 494.788SHA 03.30112S 294.775SHA 294.774SHA 294.74SHA 294.68SHA 03.30111S 03.30110S 294.792SHA 294.45SHA 294.73SHA 294.776SHA 294.52SHA 494.771SHA

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)