BEUDAMED
    FDA Registration Active 🇺🇸 United States

    04.117.907S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    62
    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
    K120070

    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

    04.117.907S 04.107.306S 02.107.412S 02.107.506S 04.117.805S 04.117.802S 04.107.508S 04.107.506S 02.107.206S 04.107.408S 02.107.410S 04.117.905S 04.117.811S 02.117.911S 04.107.406S 02.117.801S 04.107.412S 02.107.304S 02.107.406S 04.117.902S 02.117.809S 04.117.801S 04.117.807S 02.107.306S 02.107.508S 02.107.510S 02.10702S 04.107.204S 02.107.202S 04.107.304S 04.107.208S 04.107.410S 02.107.208S 02.117.907S 04.107.102S 04.107.202S 02.117.901S 02.107.512S 02.117.905S 02.118.580S 02.107.302S 04.117.901S 04.117.809S 04.117.909S 04.107.302S 02.117.902S 02.117.805S 04.107.512S 02.117.802S 04.107.510S 02.118.575S 04.107.206S 02.117.807S 04.107.308S 04.10702S 02.107.308S 02.117.909S 02.107.204S 02.107.102S 04.117.911S 02.107.408S 02.117.811S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)