BEUDAMED
    FDA Registration Active 🇺🇸 United States

    282.680S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    79
    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
    K033556

    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, Multiple Component KTT

    Proprietary Names

    282.680S 282.604S 282.607S 282.661S 282.633S 282.631S 282.643S 282.639S 282.689S 282.635S 282.671S 282.618S 282.602S 211.890S 282.679S 282.644S 282.642S 282.686S 282.646S 282.606S 282.619S 282.670S 282.641S 282.654S 282.674S 282.691S 282.640S 282.636S 282.651S 282.605S 282.632S 282.657S 282.617S 282.677S 282.648S 282.687S 282.603S 282.683S 282.638S 282.621S 282.650S 282.694S 282.672S 282.611S 282.693S 282.630S 282.634S 282.610S 282.681S 282.612S 282.690S 282.660S 282.673S 282.601S 282.620S 282.658S 282.647S 282.616S 282.688S 282.600S 282.652S 282.653S 282.659S 282.655S 282.613S 282.614S 282.692S 282.678S 282.608S 282.684S 282.637S 282.676S 282.649S 282.682S 282.656S 282.645S 282.685S 282.615S 282.695S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)