BEUDAMED
    FDA Registration Active 🇺🇸 United States

    0431.925S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    77
    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
    K070843

    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

    0431.925S 0431.964S 0431.924S 0431.957S 0431.971S 043103S 043123S 0431.970S 043119S 0431.936S 043102S 0431.978S 0431.932S 0431.958S 0431.937S 0431.940S 043125S 043100S 0431.928S 0431.961S 0431.935S 0431.959S 043127S 0431.938S 043128S 0431.950S 043126S 0431.966S 0431.927S 0431.973S 043124S 0431.948S 0431.941S 0431.979S 0431.960S 0431.955S 0431.968S 043135S 0431.954S 0431.974S 0431.930S 043101S 0431.972S 0431.939S 0431.976S 0431.967S 0431.951S 0431.953S 043132S 0431.965S 0431.931S 0431.946S 0431.929S 0431.980S 0431.934S 0431.952S 0431.977S 0431.981S 0431.949S 0431.926S 0431.933S 0431.944S 0431.975S 0431.969S 043134S 0431.956S 043130S 043122S 043129S 0431.945S 043131S 043118S 043119 043121S 0431.947S 043120S 043133S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)