BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OmniTip¿, Model 20479

    Reg #: 2011171 · FEI: 2011171 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    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
    K923191

    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

    OmniTip¿, Model 20479 OmniTip¿, Model 20481-S Ho:YAG Omni¿ Switchtip, Model 20470-S OmniTip¿, Model 20476 OmniTip¿, Model 20478 OmniTip¿, Model 20495-S OmniTip¿, Model 20481-HP OmniTip¿, Model 20479-S OmniTip¿, Model 20475-S OmniTip¿, Model 20484-HP Ho:YAG Omni¿ Switchtip, Model 20471 OmniTip¿, Model 20484-S OmniTip¿, Model 20496-S OmniTip¿, Model 20489-S OmniTip¿, Model 20484 OmniTip¿, Model 20489 OmniTip¿, Model 20495-HP Ho:YAG Omni¿ Switchtip, Model 20470 OmniTip¿, Model 20476-S OmniTip¿, Model 20474 OmniTip¿, Model 20475 OmniTip¿, Model 20481 OmniTip¿, Model 20474-HP OmniTip¿, Model 20497-HP OmniTip¿, Model 20478-S OmniTip¿, Model 20474-S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)