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510(k) Data Aggregation
K Number
K160783Device Name
Procellera
Manufacturer
Date Cleared
2016-09-07
(169 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
VOMARIS INNOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For professional 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, diabetic ulcers, first and second degree burns, surgical incisions, donor and recipient graft sites, etc.
For over-the-counter use, Procellera® antimicrobial 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, blisters, etc.
Device Description
Procellera® is a single layer, broad-spectrum antimicrobial wound 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, due to its inherent design. The device is self-contained and has no accessories.
Procellera® contains Silver and Zinc as preservatives to the dressing, to minimize or prevent the growth of microorganisms within the dressing, not at the wound site, and to help preserve 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. Procellera® may be used with other common wound treatment products such as, sutures, staples, liquid skin adhesives, or steri-strips as an adjunct to the local clinical protocols.
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