BEUDAMED
    FDA Registration Active 🇺🇸 United States

    02.230.115S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    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
    K090949

    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

    02.230.115S 04.230.113S 04.230.120S 04.230.115S 04.230.116S 02.230.119S 02.230.110S 04.230.111S 02.230.111S 04.230.110S 04.230.109S 02.230.114S 02.230.113S 02.230.112S 04.230.119S 02.230.109S 02.230.120S 04.230.117S 04.230.114S 02.230.117S 02.230.118S 04.230.118S 02.230.116S 04.230.112S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)