BEUDAMED
    FDA Registration Active 🇺🇸 United States

    238.62S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    162
    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
    K914546

    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

    238.62S 236.103S 283.64S 239.47S 283.94S 283.66S 237.94S 235.700S 236.101S 239.74S 282.72S 237.44S 236.114S 237.72S 235.701S 239.45S 283.92S 235.68S 237.24S 235.37S 237.90S 283.62S 238.38S 238.47S 283.90S 237.26S 237.52S 235.680S 283.44S 239.23S 235.60S 239.55S 238.36S 238.46S 237.995S 282.70S 236.36S 282.74S 235.70S 238.60S 237.70S 236.112S 239.43S 239.22S 236.354S 283.46S 239.84S 235.781S 239.85S 239.28S 23602S 239.88S 239.53S 238.24S 283.40S 238.68S 239.82S 236.113S 235.370S 239.78S 237.82S 239.21S 237.84S 239.62S 235.681S 282.58S 235.78S 282.78S 239.89S 237.76S 237.20S 239.30S 283.60S 238.94S 238.40S 236.260S 235.170S 235.390S 237.54S 239.57S 282.92S 235.721S 283.42S 235.600S 23613S 236.43S 239.80S 237.62S 235.29S 237.22S 237.46S 237.56S 238.49S 236.250S 237.74S 238.48S 236.400S 237.92S 237.96S 236.40S 238.98S 235.19S 237.50S 235.17S 235.601S 282.52S 237.42S 282.98S 238.64S 237.997S 238.44S 239.64S 235.270S 237.40S 239.73S 239.70S 236.352S 239.24S 235.720S 239.20S 235.39S 236.104S 239.72S 238.26S 236.430S 23611S 236.102S 238.41S 239.32S 238.96S 235.27S 239.60S 235.72S 239.81S 23603S 23612S 236.25S 238.66S 236.35S 236.350S 282.94S 238.28S 283.96S 238.42S 239.71S 236.360S 238.45S 237.66S 23601S 282.54S 236.26S 235.290S 236.111S 237.64S 282.50S 235.190S 239.86S 235.780S 237.86S 239.87S 282.90S 239.83S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)