BEUDAMED
    FDA Registration Active 🇺🇸 United States

    439.962S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    63
    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
    K050646

    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

    439.962S 239.984S 239.966S 239.993S 439.960S 239.960S 439.967S 239.961S 439.958S 239.989S 239.967S 239.963S 439.990S 239.995S 439.995S 439.996S 239.996S 439.955S 239.985S 239.991S 439.970S 239.959S 439.988S 439.987S 239.988S 239.965S 239.994S 439.954S 239.987S 239.962S 239.969S 439.984S 239.971S 439.971S 439.964S 439.969S 239.986S 239.968S 239.970S 439.985S 239.958S 439.961S 439.994S 439.956S 239.992S 239.954S 439.991S 439.963S 239.997S 439.959S 239.990S 439.986S 439.993S 239.956S 439.968S 439.966S 439.992S 439.989S 239.964S 239.957S 439.965S 239.955S 439.957S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)