BEUDAMED
    FDA Registration Active 🇺🇸 United States

    0401.436S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    53
    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
    K033071

    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
    Nail, Fixation, Bone JDS

    Proprietary Names

    0401.436S 0401.636S 0401.434S 0401.428S 0401.242S 0401.238S 0401.630S 0401.628S 0401.430S 0401.226S 0401.218S 0401.418S 040107S 0401.236S 0401.638S 0401.634S 0401.222S 0401.640S 0401.610S 040108S 0401.220S 0401.426S 0401.228S 0401.440S 0401.632S 040101S 0401.420S 0401.626S 040109S 0401.240S 0401.642S 0401.424S 040100S 0401.644S 0401.230S 040103S 0401.422S 0401.210S 0401.624S 0401.410S 0401.442S 0401.438S 040102S 0401.224S 0401.234S 0401.444S 0401.232S 0401.244S 0401.618S 0401.432S 040110S 0401.622S 0401.620S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)