BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SonicOne Plus Ultrasonic Wound Care System and Accessories

    Reg #: 2435119 · FEI: 2435119 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    MISONIX, LLC
    Registration Number
    2435119
    FEI Number
    2435119
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1938 New Hwy
    City
    Farmingdale
    State
    NY
    ZIP
    11735
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123980

    Owner / Operator

    Firm Name
    MISONIX, LLC
    Operator Number
    2435119
    Address
    1938 New Hwy
    City
    Farmingdale
    State
    NY
    Postal Code
    11735
    Country
    US
    Correspondent
    William Heard

    Products

    Device Name Product Code
    Lavage, Jet FQH
    Wound Cleaner, Ultrasound NRB

    Proprietary Names

    SonicOne Plus Ultrasonic Wound Care System and Accessories

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device