BEUDAMED
    FDA Registration Active 🇺🇸 United States

    0415.522S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    187
    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
    K040762

    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
    Nail, Fixation, Bone JDS

    Proprietary Names

    0415.522S 0404.634S 0434.234S 0434.337S 0404.734S 0404.631S 0434.434S 0415.518S 0434.661S 0415.572S 0404.246S 040401 0404.240S 0415.537S 0434.240S 0434.767S 0404.661S 0404.255S 0434.340S 0434.649S 0434.461S 0404.443S 0404.546S 0434.355S 0434.449S 0404.264S 0434.534S 0434.458S 0404.658S 0415.525S 0434.564S 0434.243S 0415.575S 0404.355S 0404.746S 0434.740S 0434.737S 0415.542S 0404.367S 040402S 0404.743S 0404.755S 0434.258S 0404.667S 0404.761S 0434.249S 0434.543S 0434.667S 0404.434S 0434.746S 0404.364S 040403S 0415.535S 0415.547S 0434.755S 0404.358S 0404.431S 0415.567S 0434.555S 0434.664S 0434.561S 0404.467S 0404.237S 0434.734S 0434.631S 0434.440S 0404.558S 0404.455S 0404.646S 0415.550S 0434.237S 0404.555S 0404.640S 0415.577S 0404.446S 0415.565S 0404.643S 0434.749S 0404.767S 0434.540S 0434.267S 0434.546S 0404.349S 0434.731S 0415.560S 0404.531S 0404.340S 0415.527S 0404.758S 0404.564S 0434.758S 0404.552S 040400S 0434.537S 0404.243S 0434.652S 0404.252S 0434.552S 0434.367S 0404.352S 0404.652S 0404.655S 0434.761S 0434.361S 0404.540S 0434.331S 0404.561S 0434.431S 0415.545S 0404.452S 0404.458S 0404.440S 0434.246S 0404.331S 0404.334S 0404.461S 0434.637S 0434.646S 0434.358S 0404.258S 0404.261S 0434.446S 0404.249S 0404.337S 0434.452S 0434.252S 0415.555S 0434.743S 0434.437S 0404.343S 0434.567S 0434.255S 0434.752S 0434.349S 0404.449S 0434.634S 0404.543S 0434.334S 0434.343S 0404.537S 0434.231S 0404.464S 0404.267S 0415.570S 0404.664S 0404.437S 0434.655S 0434.364S 0434.464S 0434.346S 0434.640S 0415.580S 0404.752S 0434.558S 0404.749S 0434.443S 0404.346S 0434.264S 0434.261S 0415.552S 0434.467S 0404.740S 0415.530S 0415.520S 0434.658S 0434.531S 0434.549S 0415.540S 0404.637S 0404.361S 0415.557S 0434.643S 0404.737S 0404.549S 0404.567S 0434.764S 0415.562S 0404.731S 0434.455S 040401S 0404.649S 0404.534S 0415.532S 0404.231S 0404.234S 0434.352S 0404.764S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)