BEUDAMED
    FDA Registration Active 🇺🇸 United States

    02.206.230S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    84
    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
    K111230

    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

    02.206.230S 02.20614S 02.20645S 02.206.240S 02.20616S 02.206.244S 02.20628S 02.20675S 02.206.300S 02.20650S 02.20656S 02.206.226S 02.20618S 02.206.310S 02.206.260S 02.206.262S 02.206.220S 02.20612S 02.206.245S 02.206.214S 02.20665S 02.20636S 02.20652S 02.206.224S 02.206.266S 02.206.270S 02.206.268S 02.20644S 02.20662S 02.20632S 02.20624S 02.20680S 02.20668S 02.20666S 02.206.275S 02.206.285S 02.206.234S 02.206.210S 02.206.252S 02.206.242S 02.20642S 02.20660S 02.20690S 02.20622S 02.20658S 02.20620S 02.20630S 02.20695S 02.206.258S 02.206.110S 02.206.232S 02.20654S 02.20646S 02.206.216S 02.206.100S 02.20670S 02.206.248S 02.206.280S 02.206.265S 02.206.246S 02.206.212S 02.206.256S 02.20640S 02.206.105S 02.20685S 02.206.250S 02.20664S 02.20626S 02.20610S 02.206.255S 02.206.295S 02.206.218S 02.20634S 02.206.222S 02.206.305S 02.206.228S 02.20638S 02.206.254S 02.206.290S 02.20655S 02.206.236S 02.206.264S 02.206.238S 02.20648S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)