BEUDAMED
    FDA Registration Active 🇺🇸 United States

    0413.468S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    141
    Establishment Types
    1
    Classifications
    2

    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
    K033618

    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
    Screw, Fixation, Bone HWC
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    0413.468S 0413.372S 0413.412S 0413.912S 0413.720S 0413.940S 0413.844S 0413.520S 0413.976S 0413.472S 0413.932S 0413.652S 0413.876S 0413.644S 0413.956S 0413.524S 0413.816S 040307S 0413.512S 0413.856S 0413.536S 041300S 0413.360S 0413.340S 0413.944S 0413.852S 0413.316S 0413.356S 0413.564S 0413.576S 0413.952S 0413.452S 0413.772S 041346S 0413.812S 0413.348S 0413.528S 041352S 0413.664S 0413.432S 0413.764S 0413.568S 0413.776S 041344S 0413.668S 0413.656S 0413.928S 0413.924S 0413.832S 0413.548S 0413.676S 0413.320S 040302S 0413.632S 0413.428S 0413.828S 040304S 0413.532S 041342S 0413.712S 0413.424S 0413.476S 041341S 0413.972S 0413.312S 0413.740S 0413.848S 041343S 0413.836S 0413.368S 0413.556S 0413.964S 0413.936S 0413.960S 0413.616S 0413.760S 041351S 0413.728S 0413.324S 040300S 041345S 0413.460S 0413.968S 0413.516S 0413.444S 0413.344S 0413.748S 0413.464S 0413.824S 0413.448S 0413.920S 0413.572S 0413.672S 041350S 0413.440S 0413.328S 0413.648S 0413.916S 0413.420S 0413.756S 0413.332S 0413.864S 0413.724S 0413.560S 0413.416S 0413.660S 041349S 0413.636S 0413.364S 040306S 040303S 0413.752S 041347S 0413.716S 0413.376S 0413.640S 0413.872S 0413.544S 0413.352S 0413.456S 0413.624S 0413.840S 0413.436S 0413.860S 040301S 0413.736S 041348S 0413.948S 0413.612S 0413.732S 0413.820S 040309S 0413.540S 0413.868S 0413.628S 0413.620S 0413.552S 0413.336S 0413.768S 040308S 0413.744S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)