BEUDAMED
    FDA Registration Active 🇺🇸 United States

    0201.324S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    36
    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
    K041911

    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

    0201.324S 426.742S 0201.322S 0201.308S 0201.306S 426.652S 226.632S 226.682S 0201.310S 426.642S 426.672S 0201.326S 426.632S 0201.302S 426.622S 226.702S 426.682S 0201.300S 426.762S 226.652S 426.702S 226.642S 0201.332S 226.762S 426.722S 226.742S 426.662S 226.722S 0201.330S 226.622S 0201.320S 226.662S 0201.312S 226.672S 0201.328S 0201.304S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)