BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GAS-COOLED FIBER, Model 20545B

    Reg #: 2011171 · FEI: 2011171 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    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
    K903154

    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

    GAS-COOLED FIBER, Model 20545B FLEXIBLE ENDOSCOPIC FIBER, Model 20591W GAS-COOLED FIBER, Model 20513C 600 MICRON BARE FIBER, Model 20501 GAS-COOLED FIBER, Model 20520C GAS-COOLED FIBER, Model 20508C GAS-COOLED FIBER, Model 20517B LAPAROSCOPIC RIGID SHEATH, Model 20584 LAPAROSCOPIC HANDPIECE, Model 20582 GAS-COOLED FIBER, Model 20544C GAS-COOLED FIBER, Model 20525B SMOKE EVACUATOR SHEATH, Model 20521 GAS-COOLED FIBER, Model 20505C GAS-COOLED FIBER, Model 20517C GAS-COOLED FIBER, Model 20518C GAS-COOLED FIBER, Model 20515B LAPAROSCOPIC HANDPIECE, Model 20581 LAPAROSCOPIC RIGID SHEATH, Model 20583 GAS-COOLED FIBER, Model 20504C GAS-COOLED FIBER, Model 20522C GAS-COOLED FIBER, Model 20503 GAS-COOLED FIBER, Model 20509C FLEXIBLE ENDOSCOPIC FIBER, Model 20591C GAS-COOLED FIBER, Model 20523W FLEXIBLE ENDOSCOPIC FIBER, Model 20590C GAS-COOLED FIBER, Model 20515C GAS-COOLED FIBER, Model 20519C FLEXIBLE ENDOSCOPIC FIBER, Model 20591B

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)