BEUDAMED
    FDA Registration Active 🇺🇸 United States

    24052S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    50
    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
    K052390

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    24052S 24045S 44047S 44042S 24036S 44036S 44037S 24048S 422.223S 222.225S 24046S 222.229S 222.226S 222.224S 222.223S 422.225S 44039S 24040S 24041S 44045S 44038S 24042S 24044S 422.227S 24053S 422.228S 24038S 422.222S 422.226S 24039S 44043S 422.229S 24054S 24043S 422.224S 222.228S 24047S 222.222S 24055S 24049S 44044S 222.221S 44040S 422.221S 222.220S 24037S 422.220S 222.227S 44041S 44046S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)