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The Kendall Curity Iodoform Packing Strip is intended for wet to dry packing of deep wounds including nasal and sinus passages. It helps control/prevent bleeding, encourages drainage and assists in removing necrotic tissue. It is indicated for general wound packing.

The proposed Kendall Curity Iodoform Packing Strip is a sterile, single-use, wound dressing consisting of a cotton gauze strip impregnated with a formulated Iodoform solution. It is packaged in HDPE amber colored bottles and is available in 14" x 5yd, 1/2" x 5yd, 1" x 5yd and 2" x 5yd sizes.

It is intended for use as a primary layer in dressing wounds such as minor burns, skin grafts, skin donor sites, as an initial layer in surgical dressings, as protective layer for injured body sites, as a seal around tubes and drains leading from the body.

The proposed Kendall Curity Petrolatum Gauze Dressing is a sterile, single-use, non-adherent dressing consisting of absorbent gauze impregnated with white petrolatum. It is packaged in metalized chevron pouches and is available in ½" x 72", 1" x 36", 3" x 9", 3" x 18", 3" x 36", 6" x 36" and 1" x 8" sizes.

The Kendall Xeroform Petrolatum Wound Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired.

The proposed Kendall Xeroform Petrolatum Wound Dressing is a sterile, singleuse, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend. It is packaged in metalized chevron pouches and is available in 4" x 3yd roll, 1" x 8", 5" x 9", 2" x 2" and 4" x 4" sizes.

Theae dressings are intended for use as a primary dressing in the management of medium to heavy draining wounds such as minor burne, abrasions and lacerations. These dressings may also be used under the care of a health tare professional for wounds such as surgical incisions, skin grafts, and dermal ulcers.

The proposed Kendall Curity Non-Adhering Dressing is a sterile, single-use, dressing consisting of cellulose acetate fabric impregnated with a specially formulated petrolatum emulsion. It is packaged in clear polyester pouches and is available in 3" x 3", 3" x 8", 3" x 16" and 14" x 4 yds sizes.

The proposed device is for use in the management of wounds which present moderate to heavy wound exudate such as dermal ulcers (i.e., venous stasis, pressure, arterial, diabetic); traumatic wounds (i.e., lacerations, punctures, abrasions or incisions); donor sites; and second-degree burns.

The Kendall CURASORB® Zn+Mg Alginate Wound Dressings are sterile, single-use, nonwoven, absorptive dressings. The off-white alginate fibers are composed of calcium, sodium, zinc and magnesium. As the dressing absorbs wound exudate it converts to a firm gel/fiber mat. This gel cushions the wound and forms a moist environment at the wound interface. The product is available in 2" x 2", 4" x 4", and 4" x 8" , 6" x 10", 12" x 24" pads, as well as 12", 24" and 36" long wound packing rope.

The Kendall FAST-CATH Pre-Lubricated Urethral Catheter is intended for sterile intermittent catherization for urine drainage from the bladder.

The Kendall FAST-CATH Pro-Lubricated Urethral Catheter is a sterile, single use system designed for the sterile intermittent cathererization for urine drainage from the bladder. The system is designed for use in both male and female patients. The system consists of a 1200cc plastic collection bag. A 14 Fr rubber or vinyl urological catheler is self contained within the collection bag. A pre-lubricated introducer up allows the catheter to be advanced through the top of the collection bag to perform wrinary cathelestization. A removable cover guards the introducer tip prior to use to maintain sterility.

Like the predicate device, the Kendall Hydrophilic Powder Wound Dressing is indicated for the management of exudating wounds such as dermal ulcers (e.g., venous stasis, pressure, arterial, diabetic), surgical incisions, traumatic wounds (e.g., lacerations, abrasions).

The proposed Kendall Hydrophilic Powder Wound Dressing is a sterile composition of maltodextrin, sodium alginate and chitosan chloride. As the powder absorbs wound exudate It converts to a gel. This gel forms a moist environment at the wound interface conducive to healing The product is available in 6 gram, 12 gram and 25 gram packets.

The Kendal! Dual Lumen Catheters are intended for use as short-term vascular access for hemodialysis. The catheters can be inserted in the femoral, subclavian or jugular vein as required.

The Kendall Dual Lumen Catheters are single use, sterile devices. The single radiopaque cannula catheters have two distinct lumina which provide simultaneous "arterial" outflow and "venous" return. The catheters have two extension tubes, sach with a color-coded in-line clamp (red for arterial outflow, blue for venous return) and luer lock adapter. The catheters are sold in 8.5, 10.0 and 11.0 Fr sizes.

The Kendall Curity Ureteral Catheter is intended to be used to inject contrast medium for fluoroscopic ureteral visualization, to direct a guidewire into the ureter and for urinary drainage.

The proposed Kendall Curity Ureteral Catheter is a sterile, single use device which facilitates preliminary procedural components of ureteroscopy. The catheter is a single lumen extrusion fabricated from nylon resin. Graduated placement markers on the catheter shaft will allow the urologist to determine the extent of catheter advancement. The proximal end of the catheter has a friction fitted luer lock adapter. The distal catheter tip will be manufactured in a cone tip, open tip or whistle tip configuration. The catheter will be sold in a standard 70 cm working length in French sizes ranging from 4.0 Fr. to 7.0 Fr.

The Kendall Curity Thoracentesis Tray is intended to be used to drain fluid from the pleural cavity.

The proposed Kendall Curity Thoracentesis Tray is a sterile, single use procedural tray containing the components required to perform a thoracentesis. This submission covers proposed changes to the aspirating needle and thoracentesis catheter. An ergonomically designed polycarbonate hub will be insert molded onto the needle cannula and a polyurethane hub insert molded onto the catheter shaft. In addition, the catheter shaft material will change from Teflon® to polyurethane. There will be no changes to the current dimensions or performance specifications. In addition, a new product code will incorporate Kendall's thoracentesis catheter-over-needle with an automatic valve that acts to occlude the proximal end of the catheter lumen. The valve is an integral part of the catheter. Once the needle is withdrawn from the valve, a spring mechanism occludes the catheter lumen.