BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIONIX OTOCLEAR SAFE IRRIGATION

    Reg #: 1526854 · FEI: 1526854 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    BIONIX, LLC
    Registration Number
    1526854
    FEI Number
    1526854
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1670 Indianwood Circle
    City
    Maumee
    State
    OH
    ZIP
    43537
    Country
    US

    Owner / Operator

    Firm Name
    BIONIX, LLC
    Operator Number
    1526854
    Address
    1670 Indian Wood Circle, --
    City
    Maumee
    State
    OH
    Postal Code
    43537
    Country
    US
    Correspondent
    Joshua A Ball

    Products

    Device Name Product Code
    Applicator, Ent Drug LRD

    Proprietary Names

    BIONIX OTOCLEAR SAFE IRRIGATION OtoClear SprayWash OtoClear Aquabot OtoClear Spray Wash OTC OtoClear Single-Use SprayWash Kit

    Establishment Types

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