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510(k) Data Aggregation
K Number
K180533Device Name
Procellera Composite Antibacterial Wound Dressing
Manufacturer
Date Cleared
2018-12-10
(285 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Vomaris Wound Care, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Rx Indications for Use: For professional use, Procellera Composite Antibacterial 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 recipient graft sites, etc. OTC Indications for Use: For over-the-counter use, Procellera Composite Antibacterial 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.
Device Description
Procellera Composite Antibacterial Wound Dressing is a three-layer dressing comprising a broadspectrum antibacterial contact layer (Procellera), a polyester-based absorbent layer, and a polyurethane semi-occlusive outer adhesive layer to keep the dressing in place and help maintain a moist wound environment. The dressing is offered in various shapes and elbow/shoulder dressings are prescription use only, while the square, rectangular and round shaped dressings are for both prescription and over-the-counter use. Embedded in the dressing are microcell batteries made of elemental zinc applied in a dot-matrix pattern to a polyester substrate. In the presence of a conductive medium such as wound exudate, water-based wound hydrogels, saline, or water, microcurrents are generated at the dressing surface due to its inherent design. Silver and zinc in the dressing help to preserve it and minimize or prevent the growth of bacteria within the dressing. Procellera Composite Antibacterial Wound Dressing may be used with other common wound treatment products such as sutures, staples, liquid skin adhesives, or steri-strips as an adjunct to local clinical protocols.
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