BEUDAMED
    FDA Registration Active 🇺🇸 United States

    04.110.741S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    24
    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
    K091644

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    04.110.741S 04.110.730S 04.110.840S 02.110.730S 04.110.751S 02.110.831S 04.110.851S 02.110.731S 04.110.740S 02.110.841S 04.110.841S 02.110.741S 02.110.751S 04.110.850S 02.110.830S 04.110.830S 04.110.831S 02.110.840S 04.110.731S 02.110.850S 02.110.750S 04.110.750S 02.110.740S 02.110.851S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)