BEUDAMED
    FDA Registration Active 🇺🇸 United States

    473.235S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    48
    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
    K973240

    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
    Pin, Fixation, Smooth HTY

    Proprietary Names

    473.235S 473.115S 473.227S 43475S 47395S 473.365S 473.345S 473.400S 473.110S 473.385S 473.560S 434.105S 473.340S 43474S 473.236S 473.405S 473.380S 473.120S 47385S 473.105S 434.100S 43485S 473.620S 473.230S 47380S 43490S 473.625S 473.150S 473.425S 473.231S 473.360S 473.225S 473.237S 473.226S 473.232S 473.545S 473.605S 473.420S 43480S 473.565S 473.585S 43473S 473.540S 473.580S 47390S 473.600S 43495S 473.100S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)