Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971337
    Device Name
    EPITECH ISLAND DRESSINGS
    Manufacturer
    RYNEL LTD, INC.
    Date Cleared
    1997-07-09

    (90 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    RYNEL LTD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rynel Epitech™ Island Dressing is intended for use in the local management of sureral incisions. Iacerations. trauma inflicted wounds, abrasions, superficial burns, secondate dressings for packed wounds and donor sites. The dressing is also appropriate for prossure diabcuc and venous stasis ulcers. It is intended to be used to protect the skin from octentral irritation, maceration and to manage exudate.
    Device Description
    The Rynel Epitech™ Island dressing pad will be manufactured from hydrophilic polyurethane foam and the border material will be either a polyurethane film or a nonwoven polyester fabric coated with a nonsensitizing acrylic pressure sensitive adhesive. The dressing will be offered as sterile stand alone dressings and will be individually packaged. Pouch material and construction will be consistent with current packaging in use by industry to safety package sterile wound dressings.
    Ask a Question

    Page 1 of 1