BEUDAMED
    FDA Registration Active 🇺🇸 United States

    274.64S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    96
    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
    K914371

    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
    Nail, Fixation, Bone JDS

    Proprietary Names

    274.64S 274.42S 274.43S 274.32S 274.55S 2740S 274.76S 274.54S 274.63S 2748S 274.60S 274.28S 274.80S 274.97S 274.56S 274.51S 274.74S 274.34S 274.27S 274.84S 274.92S 274.79S 274.17S 274.46S 274.67S 2742S 274.95S 274.29S 274.52S 2741S 274.89S 274.22S 2745S 274.88S 274.96S 274.38S 274.30S 274.58S 274.86S 274.85S 2746S 274.73S 274.31S 274.93S 274.62S 274.18S 274.21S 274.36S 274.75S 274.41S 274.61S 274.10S 274.26S 274.66S 274.50S 274.40S 274.15S 274.49S 274.19S 274.44S 274.24S 274.81S 2747S 274.65S 274.45S 274.68S 274.23S 274.48S 274.78S 274.39S 2744S 274.35S 274.47S 2743S 274.70S 2749S 274.16S 274.94S 274.57S 274.14S 274.83S 274.37S 274.82S 274.77S 274.11S 274.53S 274.20S 274.12S 274.87S 274.69S 274.25S 274.72S 274.59S 274.33S 274.13S 274.71S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)