LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990440
    Device Name
    GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE
    Manufacturer
    GENTELL
    Date Cleared
    1999-08-12

    (182 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENTELL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Pressure ulcers, stage II, III & IV wounds - Venous ulcers - 1st & 2nd degree bums
    Device Description
    Gentell hydrogel is an amorphous gel formed with a high molecular weight hydrophilic polymer, water and aloc vera. This primary wound dressing is intended to provide a moist healing environment. Gel may be removed by gentle irrigation, reducing the potential of tissue damage. Gentell hydrogel is supplied in a multidose cight ounce trigger spray boule and a four ounce tube. This product is not terminally sterilized and bioburden reduction/stasis is achieved through preservation.
    Ask a Question

    Page 1 of 1