Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020041
    Device Name
    IALUSET HYDROCOLLOID
    Date Cleared
    2002-03-14

    (66 days)

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

    INSTITUT BIOCHIMIQUE SA (IBSA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For over-the-counter use, IALUSET HYDROCOLLOID may be applied to: - abrasions - lacerations - minor cuts - minor scalds - minor burns Under the supervision of a physician, IALUSET HYDROCOLLOID may also be applied to: - leg ulcers (venous stasis ulcers, arterial ulcers) - diabetic ulcers - pressure ulcers (stage I IV) - surgical wounds (postoperative, dermatological excisions, donor sites) - burns (first and second degree only) - traumatic wounds
    Device Description
    IALUSET HYDROCOLLOID is a 10 cm x 10 cm wound dressing comprised of an inner layer of hydrocolloids (containing sodium hyaluronate and sodium chondroitin sulfate) which are incorporated into an adhesive matrix and spread between a polyurethane film and a silicone release liner. The dressing absorbs wound exudate, thereby allowing for a moist environment that is conducive to normal wound healing. It does not adhere to the wound, which minimizes both pain and damage to the underlying tissue when the dressing is removed.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1