BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PowerFlex, FlexMAX®, Model G200

    Reg #: 2011171 · FEI: 2011171 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    2011171
    FEI Number
    2011171
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4900 Gifford Ave
    City
    Los Angeles
    State
    CA
    ZIP
    90058
    Country
    US

    Regulatory Submissions

    510(k) Number
    K973172

    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
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    PowerFlex, FlexMAX®, Model G200 FlexMAX®, Model B200SMA FlexMAX®, Model B200 FlexMAX®, Model 20017M-SMA FlexMAX®, Model B200-5M FlexMAX®, Model 20025M-SMA PowerFlex, FlexMAX®, Model G200SMA FlexMAX®, Model S550SMA FlexMAX®, Model 20017-M FlexMAX®, Model S1000 FlexMAX®, Model S365SMA FlexMAX®, Model B365 FlexMAX®, Model 20021-M FlexMAX®, Model 20015-M FlexMAX®, Model 20021M-SMA FlexMAX®, Model B200-5MSMA FlexMAX®, Model S200 FlexMAX®, Model 20025-M FlexMAX®, Model S365 FlexMAX®, Model S1000SMA FlexMAX®, Model B365SMA FlexMAX®, Model S200SMA FlexMAX®, Model S550

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)