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The StatGuard® Hemostatic Patch is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites. The StatGuard® Hemostatic Dressing is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites.

The StatGuard® Devices are based on a non-woven fabric derived from chitosan fibers. The hemostatic properties of chitosan are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the chitosan material will turn into a gel-like condition to absorb the blood. It promotes control of moderate to severe wound bleeding and exudates absorption, and promotes coagulation. The dressing provides a barrier to bacterial penetration through the dressing and has antibacterial properties that reduce bacterial growth within the dressing. No clinical studies have been conducted on the subject device and the clinical benefit of this antibacterial property is unknown. The StatGuard® Hemostatic Patch is made of the non-woven fabric derived from chitosan fibers with a polyurethane backing. The StatGuard Hemostatic Patch is a 2" by 2" dressing that is placed directly over a wound for external control of bleeding. The Patch may be used with patients following a vascular procedure, hemodialysis, or other procedures resulting in bleeding wounds. The StatGuard Hemostatic Patch is individually packaged in a peelable foil pouch and is sterilized by gamma irradiation. The hemostatic properties of chitosan enhance the ability of the StatGuard Hemostatic Patch to control bleeding. The StatGuard® Hemostatic Dressing is made of the non-woven fabric derived from chitosan fibers with the addition of a backing that extends past the margins of the patch, with a pressure sensitive adhere to adhere to the patient. The StatGuard Hemostatic Dressings are provided in various sizes. The Dressing may be used with patients who have wounds that are bleeding or may be prone to bleeding. The hemostatic properties of chitosan enhance the ability of the StatGuard Hemostatic Dressing to control bleeding. The StatGuard® Hemostatic Dressings are packaged in a polyester laminated film pouch. Sterilization is by gamma radiation.