BEUDAMED
    FDA Registration Active 🇺🇸 United States

    280.454S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    192
    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
    K791619

    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

    280.454S 28121S 28140S 281.550S 280.510S 280.465S 281.75S 281.970S 281.140S 281.312S 281.54S 281.64S 28160S 2800S 281.720S 281.480S 280.800S 280.350S 281.421S 281.730S 281.740S 281.505S 280.485S 28120S 280.50S 281.34S 281.118S 281.210S 28181S 281.170S 280.150S 281.131S 281.17S 281.214S 281.660S 281.86S 281.416S 281.100S 280.700S 281.180S 280.900S 280.400S 281.418S 281.84S 280.99S 281.850S 281.540S 281.35S 281.220S 280.65S 280.540S 281.308S 281.230S 281.280S 28150S 280.90S 280.520S 280.80S 281.340S 280.250S 280.505S 281.820S 281.620S 281.316S 28110S 280.501S 281.65S 280.490S 281.66S 280.495S 281.900S 281.240S 281.940S 281.925S 280.30S 280.504S 281.400S 281.36S 281.48S 28114S 28050S 280.525S 281.74S 281.314S 281.212S 280.55S 281.630S 281.840S 281.40S 281.11S 280.20S 280.750S 280.470S 281.530S 281.24S 280.100S 281.260S 280.500S 281.110S 281.360S 28000S 281.750S 280.200S 281.504S 28112S 280.950S 281.430S 280.600S 281.44S 281.930S 281.45S 281.980S 280.300S 281.320S 281.18S 281.200S 281.402S 281.13S 281.640S 280.70S 281.14S 280.650S 281.12S 281.15S 281.46S 280.15S 280.60S 280.535S 2815S 280.455S 281.41S 281.760S 280.45S 28131S 281.650S 281.55S 280.480S 280.530S 280.550S 281.350S 280.990S 280.450S 281.420S 2814S 280.475S 281.950S 281.560S 281.120S 280.850S 281.310S 281.830S 280.95S 281.410S 281.202S 281.460S 281.860S 280.10S 280.40S 281.520S 280.515S 280.35S 2816S 281.414S 281.102S 281.330S 281.16S 281.960S 281.130S 281.56S 281.160S 281.208S 281.440S 281.506S 280.25S 281.250S 281.216S 281.503S 280.451S 281.26S 280.85S 280.75S 281.502S 281.990S 281.450S 280.460S 281.150S 281.190S 280.545S 281.10S 281.25S 281.85S 2805S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)