BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SurgENT Sinus Irrigation Catheter

    Reg #: 3006845489 · FEI: 3006845489 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ONDINE RESEARCH LABORATORIES/ONDINE BIOMEDICAL INC. (US)
    Registration Number
    3006845489
    FEI Number
    3006845489
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    19017 120TH AVE NE STE 102
    City
    Bothell
    State
    WA
    ZIP
    98011
    Country
    US

    Owner / Operator

    Firm Name
    Ondine Biomedical Inc.
    Operator Number
    10049666
    Address
    19017 120Th Ave NE, Ste. 102
    City
    Bothell
    State
    WA
    Postal Code
    98011
    Country
    US
    Correspondent
    Roger C Andersen

    Products

    Device Name Product Code
    Catheter, Balloon Type GBA

    Proprietary Names

    SurgENT Sinus Irrigation Catheter Champion Debrider Sinus Irrigation Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device