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The Reprocessed Hand Activated Sealer/Divider can be used during open procedures to seal vessels up to and including 7mm, lymphatics and tissue bundles. The Hand Activated Sealer/Divider can also be used to seal pulmonary vasculature but only when used with the ForceTriad™ energy platform. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Hand Activated Sealer/Divider is an instrument that works exclusively with the ForceTriad™ energy platform (not within the scope of this submission) to seal vessels up to and including 7 mm. seal pulmonary vasculature, lymphatics and tissue bundles. The instrument's shaft diameter is 13.5 mm (oval), length is 18 cm and shaft rotation is 180 degrees.

Scissor instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue. The instrument, model 5DCS, is validated with the US Surgical Force FX-C generator and is only to be used with this generator.

Endoscopic instruments consist of a rigid plastic handpiece with loop handles connected to the distal end scissors or jaws by an elongated, narrow-diameter insulated barrel or shaft. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The handbiece loop handles operate the jaws. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. The blades or jaws of endoscopic instruments can deliver a cauterizing current that enters the instrument through the unipolar cautery connector on the handpiece, runs down the insulated shaft and through the tissue in the blades or jaws. Monopolar electrocautery is possible only with instruments equipped with a cautery pin in conjunction with a compatible electrosurgical unit and patient grounding pad.

When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with connectors for pump attachment. Only the compression sleeves are reprocessed.

The Reprocessed CS Bi-Directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

The reprocessed Biosense Webster® Coronary Sinus (CS) EZ STEER™ Diagnostic Electrophysiology (EP) Catheter (hereinafter CS Bi-Directional Diagnostic EP Catheter) is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 7FR catheter with a usable length of 115 cm. The catheter has a high-torque shaft with a braided bi-directional deflectable tip section containing platinum electrodes that can be used for recording and stimulation. Two asymmetric curve types, DF and FJ, are available providing two 180° opposed, single plane curves. The rocker lever located on the handpiece is used to deflect the tip section. A Friction Control Knob is located on the opposite side of the rocker lever and can be rotated clockwise to lock both the tip curve and rocker lever in place. The high torque shaft allows the plane of the curved tip to rotate, enabling accurate positioning of the catheter tip at the preferred site.

The Reprocessed Ultrasonic Curved Shears is indicated for soft tissue incisions when bleeding control and minimal thermal injury is desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures and other open procedures.

The Ultrasonic Curved Shears is an instrument consisting of a scissor handle housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). The instrument has a working length of 9cm, an active blade length of 16mm, and utilizes a curved blade and clamp arm. The Ultrasonic Curved Shears device allows for the cutting and coagulation of vessels up to and including 5mm in diameter. The Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are designed to operate with the Harmonic™ Generator 300 (GEN04) and Harmonic™ Blue Hand Piece (HPBLUE).

Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Trocars and cannulae are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery. The Trocar Cannula is available with a threaded sleeve with a 5mm inner diameter and 100mm length. The Cannula is equipped with a sealing system for maintenance of pneumoperitoneum during insertion and withdrawal of instruments and with a luer stopcock port for insufflation and desufflation of the operative cavity. Trocar Obturator is available in bladeless configuration sized 5 mm.. Bladeless optical obturators are equipped with a clear tip and a video laparoscopy channel to allow trocar insertion under direct visual quidance and minimize the risk for internal injury The reprocessed device has the same intended use as the original device and does not incorporate new technology or design changes.

The Reprocessed Ultrasonic Coagulating Shears with Scissor Handle and Hand Control are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The shears can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general; plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures and other open procedures.

The Ultrasonic Coagulating Shears is an instrument consisting of a scissor handle housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). An audible and tactile mechanism is integrated into the handle housing to indicate full closure. The Ultrasonic Coagulating Shears is 18 cm long, shaft diameter of 8.5 mm, with an active blade length of 18 mm. The blade and clamp arm are straight allowing them to function through an incision without the use of a trocar. The Ultrasonic Coagulating Shears allows for the cutting and coagulation of vessels up to and including 5 mm in diameter. The Ultrasonic Coagulating Shears is designed to operate with the Harmonic TM Generator 300 (GEN04) and the Hand Piece (HP054).

Reprocessed 3D Diagnostic Ultrasound Catheters are indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO® XP EP Navigation System Version 9 or greater.

3D Diagnostic Ultrasound Catheters are specially designed catheters that provide two-dimensional imaging using an ultrasound transducer and three-dimensional location information using a location sensor. The ultrasound transducer and location sensor are at the distal tip of the catheter and can be positioned for ultrasound imaging and 3D mapping by a steering mechanism that rotates the catheter tip and variable deflection. 3D Diagnostic Ultrasound Catheters incorporate a handpiece, a flexible shaft and a distal tip section containing an ultrasound transducer and a location sensor. The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter 3-D location sensor provides location information to the CARTO® XP EP Navigation System (mapping system). The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter is 10 French with a 90 cm insertion length.

Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the LASSO® 2515 Variable Circular Mapping Catheter and the Reflexion Spiral 140 Variable Radius Catheter are designed for electrophysiological mapping of the atria of the heart.

Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.

Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the Lasso® 2515 Variable Circular Mapping Catheter is designed for electrophysiological mapping of the atria of the heart.

Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.