BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 7MM BLU TUBE +2/CA Portex UltraPerc Singl

    Reg #: 1319639 · FEI: 1000138054 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1319639
    FEI Number
    1000138054
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    84 Park Rd
    City
    Queensbury
    State
    NY
    ZIP
    12804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041348

    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
    Tube Tracheostomy And Tube Cuff JOH

    Proprietary Names

    ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 7MM BLU TUBE +2/CA Portex UltraPerc Singl ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 8MM BLU TUBE +2/CA Portex UltraPerc Sing ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 9MM BLU TUBE +2/CA Portex UltraPerc Sing ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 7MM BLUS TUBE +2/CA Portex UltraPerc Sin ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 9MM BLUS TUBE +2/CA Portex UltraPerc Sin ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 8MM BLUS TUBE +2/CA Portex UltraPerc Sin Portex Ultraperc K041348 ULTRAPERC PERC S/S DILATION TRACHY KIT FOR 7, 8, 9MM TUBES, SOFT INTRODUCERS, 2/CA Portex UltraPerc Percutaneous T ULTRAPERC LOCAL INFILTRATION (SDD) W/DRUGS + 10/CA Portex UltraPerc Local Infiltration Tray

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)