BEUDAMED
    FDA Registration Active 🇺🇸 United States

    209.740S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    22
    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
    K962011

    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

    Proprietary Names

    209.740S 209.775S 209.735S 209.955S 208.970S 209.960S 208.955S 208.965S 209.980S 209.755S 209.745S 208.980S 209.780S 209.760S 209.970S 209.765S 208.960S 209.770S 208.975S 209.975S 209.965S 209.750S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)