BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Lithoclear®Gel for Lithotripsy

    Reg #: 2523891 · FEI: 2523891 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NEXT Medical Products Company
    Registration Number
    2523891
    FEI Number
    2523891
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    45 COLUMBIA RD
    City
    Branchburg
    State
    NJ
    ZIP
    08876
    Country
    US

    Regulatory Submissions

    510(k) Number
    K883917

    Owner / Operator

    Firm Name
    NEXT Medical Products Company
    Operator Number
    10041610
    Address
    45 COLUMBIA RD
    City
    Branchburg
    State
    NJ
    Postal Code
    08876
    Country
    US
    Correspondent
    Julia Jacobson

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Lithoclear®Gel for Lithotripsy Clear Image Singles® Clear Image®Ultrasound Gel Goppli Gel

    Establishment Types

    Manufacture Medical Device