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The OtoSet - Ear Cleaning System (OtoSet) is indicated to remove earwax from the external ear canal with irrigation and suction in adults.

The OtoSet – Ear Cleaning System (OtoSet) is an automated ear irrigation device used to remove earwax, or cerumen, from the external ear canal of adults. The OtoSet consists of an adjustable head strap, two ear units, two single-patient-use disposable ear tips, and two singlepatient-use disposable waste containers. In addition to the disposable ear tips and waste containers, each ear unit houses a solution container, liquid pump, vacuum pump, printed circuit board electronics, rechargeable batteries, and electrical and plumbing elements to connect these items together. The device can be used to clean the left, right, or both external ear canals at the same time. The OtoSet includes components that come in contact with the patient during use. The singlepatient-use disposable ear tips, ear pads and head strap pad (all made of silicone rubber) are surface contacting components having limited contact duration (< 24 hours) with intact skin.

The Red Head and Jordy Connection System is indicated for use as a liposuction adipose (fatty) collection system used in the aesthetic body contouring and collection of autologous adipose tissue. The Red Head and Jordy Connection System is intended to be used in the following surgical procedures: - Aspiration of adipose (fatty) tissue - Harvesting adipose (fatty) tissue - Filtering adipose (fatty) tissue - Extraction of autologous adipose (fatty) tissue

Device Functions: - 1. Single Use closed loop system collection device (same) - 2. Canister contains ports on lids for interface between: Jordy Connection System to Canister and aspirator pump. - 3. Connection system to connect tubing to interfaces - 4. Funnel to enable fat to separate from fluids - 5. Channel for fluid evacuation. - Toomey Syringe to extract fat from device. 6. Device Design: - 1. Owner holds patent to predicate device and has improved performance and safety through this design. - 2. Non-Sterile, Single Use - 3. Canister able to withstand 30 in/Hg (18 in/Hg maximum vacuum used for collection of adipose (fatty tissue) for harvesting. - 4. Tissue enters canister through collection port on canister lid. - 5. Funnel perforation large enough for only adipose (fatty) tissue to be collected - 6. Waste material is removed from canister by closing valve on center of lid. - 7. Remaining adipose (fatty) tissue can be withdrawn through tissue port on bottom of center of canister for autologous adipose (fatty) tissue extraction. Physical Properties and Materials Used: - 1. Canister, Funnel and Outer Lid made from Polycarbonate - 2. Evacuation spout and pinch clamps made from Polypropylene - 3. Tubing made from silicone Intended use of Device: For use in aspirating subcutaneous fatty tissue including autologous fat collection.

The Single Cannula Extended Applicator is intended for medical purposes to irrigate or instill fluids to a wound or body cavity.

The Single Cannula Extended Applicator has two components: an applicator instrument and a replaceable spray tip. The spray tip is assembled to the instrument by the user. The assembled applicator product is installed on a standard medical syringe, and allows fluids to be applied from the syringe to a treatment site that is otherwise difficult to access. The entire device is packaged sterile and labeled for single-use. The applicator instrument contains a stainless steel hypodermic tube with a molded polymer luer lock connector on the input (proximal) end. It is enclosed in a stainless steel sheath that provides rigidity and allows the device to effectively seal off in a 5mm endoscopic cannula. A replaceable molded polymer spray tip is attached to the output (distal) end of the sleeve by the user. A replacement tip is included in the package.

The Tissu Trans Filtron is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus. Tissu Trans Filtron is used in the aspiration, harvesting, filtering and transferring of autologous tissue, Tissu Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: - Plastic and Reconstructive Surgery - Neurosurgery - Gastrointestinal and Affiliated Organ surgery - Urological Surgery - Orthopedic surgery - Gynecological Surgery - Thoracic surgery - Laparoscopic Surgery

The Tissu Trans Filtron is provided in a sterile, two piece packaged assembly: The Tissu Trans Filtron. The Tissu Trans Filtron is a single-use, sterile, disposable device designed to utilize an FDA, cleared house vacuum to create suction within the physician supplied hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the autologous tissue into the collection canister. The Tissu Trans Filtron is a sterile, single-use, manual device consisting of a medical grade polycarbonate canister, a medical grade polypropylene lid with various ports, medical grade silicone connection tubings for aspiration of waste, harvesting of tissue and transferring of filtered autologous tissue. A polypropylene clamp is included for clamping off the tubing as needed. A medical grade polyester mesh filter lining is contained within the canister.

For use in aspirating subcutaneous fatty tissue including autologous fat collection.

Device function: 1. Contains port interfaces between: Canister to tubing & aspirator to canister. 2. Sterile tubing to connect the interfaces 3. Funnel to interface port to tubing. 4. Syringe to collect fat. Device design: 1. Contents subjected to sterility Material used: Plastic Canister, Syringe, silicone tubing Physical properties: Plastic & Silicone

The GYNECARE PROSIMA* Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH* PS Nonabsorbable PROLENE Soft Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor, either as mechanical support or bridging material for the fascial defect. The Systems provide maintenance of the vaginal canal during the period of healing following surgical repair of vaginal wall prolapse, while supporting the position of the Mesh Implants.

The GYNECARE PROSIMA Anterior, Posterior, and Combined Pelvic Floor Repair Systems consist of pre-cut GYNECARE GYNEMESH PS Mesh Implant(s), and instruments to facilitate Mesh Implant placement and postoperative support.

Tissu-Trans™ is intended to be used when harvesting, filtering and transferring of autologous fat is desired. Tissu-Trans™ is a piston syringe used in the aspiration harvesting, filtering and transferring of autologous tissue.

Tissue-Trans™ is a sterile, single use, disposable syringe device used in the harvesting, filtering and transferring of autologous fat. Used by acinso asounding procedures,Tissue Trans™ simplifies and reduces the steps prysiolane in the collection and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until re-injection. Tissu-Trans™ is a piston syringe device comprised of a small 10cc syringe with Luer Lock tip that has small holes drilled into its barrel. This small10cc syringe is placed inside a larger 60cc barrel type tube, which is attached to a medical grade tubing and aspiration machine. As the autologous fat is collected into the 10cc syringe, the waste products are strained through the holes in the 10cc syringe into the large 60cc barrel tube and suctioned into a waste container. The small syringe is removed from the large 60cc tube, a sleeve is attached to the small 10cc syringe around the barrel and the autologous fat is re-injected into the patient at desired locations.

The PSI TEC III Peristaltic Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The PSI TEC III Peristaltic Infiltration Pump is not intended for intravenous use.

The principles of operation and technology incorporated in the PT-PINF III pump are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. The PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing and assist in moving fluid from an I.V. fluid bag to the infiltration site. As with all peristaltic pumps, the PT-PINF III contacts only the tubing/tractor and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.

The Subcutaneous Illuminator is indicated for transillumination and irrigation during endoscopic resection of superficial varicosities of the lower extremities.

The Smith & Nephew Subcutaneous Illuminator transfers light to the surgical site via glass fiber optics and includes irrigation via an irrigation channel. The Subcutaneous Illuminator allows it to gain access to the surgical site.

General surgical fluid irrigation and infiltration. The Psi-Tec Syringe Infusion Pump and accessories indications for use are for General Fluid Irrigation/Infiltration.

The principles of operation and technology incorporated in the Psi-Tec Svringe Infusion Pump and accessories are to provide controlled fluid delivery by utilizing a disposable, pneumatically driven syringe cartridge attached to tubing, that can propel and monitor fluid volumes delivered into a surgical site by the system.