BEUDAMED
    FDA Registration Active 🇺🇸 United States

    04.211.234S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    84
    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
    K100776

    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
    Screw, Fixation, Bone HWC

    Proprietary Names

    04.211.234S 02.211.260S 02.211.265S 04.211.222S 02.211.213S 02.211.261S 02.211.231S 04.211.239S 04.211.260S 02.211.250S 04.211.242S 02.211.251S 02.211.233S 02.211.236S 02.211.245S 02.211.212S 04.211.243S 02.211.224S 04.211.250S 04.211.215S 04.211.231S 04.211.213S 04.211.224S 02.211.215S 02.211.243S 04.211.212S 04.211.246S 04.211.230S 04.211.238S 04.211.261S 04.211.247S 02.211.220S 04.211.240S 02.211.253S 02.211.239S 02.211.240S 04.211.255S 04.211.265S 04.211.237S 02.211.238S 02.211.242S 02.211.221S 04.211.241S 02.211.258S 04.211.252S 02.211.252S 02.211.234S 04.211.256S 04.211.210S 04.211.232S 02.211.257S 02.211.255S 04.211.235S 04.211.258S 02.211.247S 02.211.266S 02.211.222S 04.211.211S 04.211.251S 04.211.233S 02.211.210S 02.211.230S 04.211.245S 02.211.241S 02.211.244S 04.211.266S 04.211.257S 04.211.236S 02.211.232S 02.211.211S 04.211.221S 02.211.214S 04.211.220S 02.211.254S 04.211.214S 04.211.254S 04.211.253S 04.211.244S 02.211.235S 04.211.259S 02.211.259S 02.211.237S 02.211.256S 02.211.246S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)