BEUDAMED
    FDA Registration Active 🇺🇸 United States

    04.114.506S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    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
    K090047

    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

    04.114.506S 04.114.502S 02.114.502S 04.114.505S 02.114.503S 02.114.504S 04.114.507S 02.114.510S 04.114.509S 04.114.504S 04.114.513S 02.114.506S 02.114.513S 04.114.514S 02.114.507S 04.114.510S 02.114.505S 02.114.509S 02.114.514S 04.114.503S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)