BEUDAMED
    FDA Registration Active 🇺🇸 United States

    S-LLF200TG FIBER,200uM,LITHOTRIPSY SureFlex¿200 Lithotripsy Fiber, 1x, Blue

    Reg #: 2011171 · FEI: 2011171 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    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
    K050108

    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

    S-LLF200TG FIBER,200uM,LITHOTRIPSY SureFlex¿200 Lithotripsy Fiber, 1x, Blue S-LLF273TG FIBER,273uM,LITHOTRIPSY SureFlex¿273 Lithotripsy Fiber, 1x, Blue R-LLF910 FIBER,910uM,REUSABLE SureFlex¿910 Lithotripsy Fiber, 5x, Blue S-LLF150TG FIBER,150uM,LITHOTRIPSY SureFlex¿150 Lithotripsy Fiber, 1x, Blue S-LLF365 FIBER,365uM,LITHOTRIPSY SureFlex¿365 Lithotripsy Fiber, 1x, Blue R-LLF550 FIBER,550uM,REUSABLE SureFlex¿550 Lithotripsy Fiber, 5x, Blue R-LLF273TG FIBER,273uM,REUSABLE SureFlex¿273 Lithotripsy Fiber, 5x, Blue R-LLF150TG FIBER,150UM, REUSABLE SureFlex¿150 Lithotripsy Fiber, 5x, Blue S-LLF550 FIBER,550uM,LITHOTRIPSY SureFlex¿550 Lithotripsy Fiber, 1x, Blue R-LLF200TG FIBER,200uM,REUSABLE SureFlex¿200 Lithotripsy Fiber, 5x, Blue R-LLF365 FIBER,365uM,REUSABLE SureFlex¿365 Lithotripsy Fiber, 5x, Blue S-LLF910 FIBER,910uM,LITHOTRIPSY SureFlex¿910 Lithotripsy Fiber, 1x, Blue

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)