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QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. Cardiac surgical procedures: for temporary control of mild and moderate bleeding in cardiac surgical procedures, as well as in patients displaying class III or class IV bleeding. Bone surfaces following sternotomy: to control bleeding from bone surfaces following a sternotomy.

QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes and configurations. The device is available in single or multipacks.

QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.

QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes. The device is available in single or multipacks.

QuikClot® Radial® is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in (a) patients on druq/induced anti-coagulation treatment and (b) patients not on druq/induced anti-coaqulation treatment.

The QuikClot® Radial® consists of a rolled hemostatic dressing to be used in conjunction with Tegaderm™, Coban™, or equivalent adhesive bandage (not supplied). The roll is a soft, white, sterile, hydrophilic, kaolin-impregnated gauze. Kaolin is a hemostatic agent that functions to stop bleeding in anti-coagulated patients, and is used in the same form and amount as in the predicate device. The kaolin is bound to the gauze in the same manner as in the predicate device. The QuikClot® Radial® is configured in 0.75" diameter x 1.5" length. The device is packaged for aseptic removal in a peelable foil pouch. The dressing is a single-use device that has suface contact with breached or compromised skin for a limited duration (≤24 hours).

D2 Hemostatic Dressing is intended for use as a hemostatic dressing for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.

The D2 Hemostatic Dressing is composed of kaolin (hemostatic agent) bound to a non-woven gauze (polyester-rayon substrate). D2 Hemostatic Dressing is provided in a sterile, intuitive, simple to use dressing format that conforms readily to the wound.

QuikClot® Hemostatic Dressing is intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

The QuikClot Hemostatic Dressing utilizes a layered clay hemostat, kaolin USP, which is bound to medical gauze using glycerin USP. QuikClot Hemostatic Dressings are provided in a sterile, intuitive, simple to use dressing format that conforms readily to the wound. The QuikClot Hemostatic Dressing that is the subject of this submission is described in detail in K072474.