BEUDAMED
    FDA Registration Active 🇺🇸 United States

    02.111.200S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    46
    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
    K081071

    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

    02.111.200S 04.111.225S 04.111.235S 04.111.205S 04.111.180S 02.111.220S 04.111.220S 02.111.240S 02.111.235S 04.111.175S 02.111.170S 02.111.160S 04.111.160S 02.111.185S 02.111.180S 04.111.195S 04.111.155S 04.111.230S 02.111.205S 04.111.250S 04.111.215S 02.111.195S 02.111.155S 04.111.255S 02.111.175S 02.111.250S 04.111.165S 04.111.210S 02.111.225S 02.111.230S 04.111.170S 04.111.190S 04.111.245S 02.111.150S 04.111.260S 02.111.255S 04.111.185S 02.111.190S 02.111.210S 02.111.165S 02.111.260S 04.111.150S 02.111.245S 02.111.215S 04.111.200S 04.111.240S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)