BEUDAMED
    FDA Registration Active 🇺🇸 United States

    239.912S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    48
    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
    K013248

    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

    239.912S 04.112.514S 239.901S 239.917S 239.921S 04.112.531S 238.710S 02.112.531S 04.112.527S 239.916S 239.909S 04.112.523S 239.904S 238.701S 04.112.515S 238.704S 02.112.527S 04.112.511S 04.112.522S 02.112.522S 02.112.511S 02.112.519S 02.112.510S 238.707S 02.112.530S 239.905S 02.112.514S 02.112.523S 238.703S 04.112.510S 239.920S 239.908S 02.112.515S 238.706S 238.709S 238.711S 04.112.518S 238.708S 02.112.518S 04.112.526S 239.913S 238.705S 02.112.526S 238.702S 04.112.530S 04.112.519S 239.900S 238.700S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)