BEUDAMED
    FDA Registration Active 🇺🇸 United States

    02.122.324S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    62
    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
    K080109

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW

    Proprietary Names

    02.122.324S 02.122.611S 02.122.596S 02.122.339S 02.122.585S 02.122.353S 02.122.551S 02.122.571S 02.122.565S 02.122.581S 02.122.373S 02.122.384S 02.122.586S 02.122.306S 02.122.386S 02.122.615S 02.122.651S 02.122.570S 02.122.376S 02.122.555S 02.122.336S 02.122.333S 02.122.575S 02.122.621S 02.122.590S 02.122.313S 02.122.601S 02.122.580S 02.122.610S 02.122.616S 02.122.382S 02.122.326S 02.122.366S 02.122.303S 02.122.595S 02.122.550S 02.122.393S 02.122.560S 02.122.338S 02.122.591S 02.122.337S 02.122.620S 02.122.388S 02.122.335S 02.122.356S 02.122.605S 02.122.606S 02.122.316S 02.122.330S 02.122.566S 02.122.561S 02.122.392S 02.122.391S 02.122.576S 02.122.328S 02.122.334S 02.122.600S 02.122.363S 02.122.581 02.122.332S 02.122.556S 02.122.390S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)