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510(k) Data Aggregation

    K Number
    K130350
    Device Name
    PROCELLERA
    Date Cleared
    2013-07-02

    (140 days)

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

    VOMARIS INNOVATIONS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For over-the-counter use, Procellera® wound dressing is intended for the management of wounds to provide a moist wound environment and is indicated for superficial wounds such as minor cuts, scrapes, irritations, abrasions, blisters, etc. For prescription use, Procellera® antimicrobial wound dressing is intended for the management of wounds to provide a moist wound environment and is indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, first and second degree burns, surgical incisions, donor and/or recipient graft sites, etc.
    Device Description
    Procellera® is a single layer dressing; it consists of a polyester substrate containing elemental silver and elemental zinc bound to the surface by a biocompatible binder in a well-characterized dot matrix pattern. In the presence of a conductive fluid, such as wound exudate or moisture, a small amount of current is produced at the surface of the device, and it occurs because it is inherent to its design. The device is self-contained and has no accessories. Silver and zinc in the dressing produce microcurrent which helps the dressing to be preserved and to minimize or prevent growth of microorganisms within the dressing. Procellera® is a primary contact layer dressing and it should be used under a secondary dressing or bandage, which keeps it in place and helps maintain a moist wound environment.
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