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The Dornier Bipolar Cable is indicated to be used with a compatible electrosurgical generator and an HF electrode for endoscopic treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.

The Dornier Bipolar Cable is a sterile, single use, disposable device that allows connection of an electrosurgical generator to an HF electrosurgical resection and vaporization electrode. The outer body of the Dornier Bipolar Cables are constructed of a medical grade thermoplastic elastomer. The cable consists of a double wire zip cord with one plug end which has four (4) banana and one (1) straight pin, style of connector that is then attached to the generator. The other end is separated and has two (2) overmolded connectors, one male pin on a wire and one female pin on a wire which are compatible with the HF Electrode.

The Dornier MAGELLAN Ureteral Access Sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments. The target population is for adults only (at least 22 years old).

The Dornier MAGELLAN Ureteral Access Sheath is a two component ureteral dilatation system that provides an open conduit to the upper urinary tract to facilitate Ureteroscopy, which contains a single lumen for injection of fluids as well as passage of endoscopes and related instruments. The packaged product includes a Hydrophilic-coated Dilator with a locking mechanism and a Hydrophilic-coated sheath with hub. The Access Sheath is a sterile, single use, disposable device that allows access to the ureter to facilitate scope and urological tool passage. The Dornier MAGELLAN Ureteral Access Sheaths are constructed of a medical grade thermoplastic elastomer (Pebax®). This material has been USP Class VI tested. All colorants used are compliant with FDA standards.

The Dornier EQUINOX Balloon Dilatation Catheter is indicated for dilation of the urinary tract.

The Dornier EQUINOX Balloon Dilatation Catheter is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow ureteral segments. The Dornier EQUINOX Balloon Dilatation Catheters are sterile, single-use devices. The EQUINOX Balloon Dilatation Catheters are available in 5.8 French (Fr) diameter, with a catheter length of 80 centimeters (cm). There will be three (3) balloon diameters, (4mm, 5mm and 6mm) and two (2) balloon lengths (4cm and 10cm) The Dornier EQUINOX Balloon Dilatation Catheters are constructed of a medical grade nylon material. This material has been USP Class VI tested. The base material is compounded with BaSO4 to render the Dornier EQUINOX Balloon Dilatation Catheter radiopaque under x-ray fluoroscopy. The catheter also has radio-opaque marker bands on the proximal and distal ends of the balloon for visualization during use. All colorants used are compliant with FDA standards.

The Dornier CASCADE Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.

The Dornier CASCADE Ureteral Stents are sterile, single-use devices. The stents are available in 4.9 to 8.0 French (Fr) diameter, with lengths ranging from 14.0 to 32.0 centimeters (cm). The stents are constructed of a thermoplastic polyurethane elastomer. The base polyurethane material is compounded with BaSO4 to render the stent radiopaque under x-ray fluoroscopy. Drainage holes extend along the body of the stent as well as on the pigtails to provide drainage. The stents are secured in the urinary tract with pigtail loops on the proximal and distal ends. A monofilament tether for repositioning and removal of the device is located on the proximal pigtail (bladder end) of the stent. Along the stent are graduation marks to provide visualization during stent advancement and placement. The CASCADE Ureteral Stent includes a pigtail straightener, a small polymer tube to aid in placement over a wire guide. The pigtail straightener is removed prior to use. The CASCADE Ureteral Stents are labeled for a maximum 30day indwell time. The stents are packaged into a pre-formed tray and sealed within a Tyvek pouch. The individually sealed Tyvek pouches are labeled with identification labeling and then packaged into a corrugated shipping box. The packaged stents are sterilized by a contract sterilizer using ethylene oxide.

The Dornier MINNOW Ureteral catheter is indicated for access and catheterization of the urinary tract, including the following applications: Delivery of contrast media Drainage of fluids from the urinary tract Delivery of irrigation fluids to the urinary tract Navigation of a tortuous ureter Access, advancement, or exchange of wire quides The target population is for adults only (at least 22 years old).

The MINNOW Ureteral Catheter is a sterile single lumen medical grade thermoplastic elastomer (Pebax®) catheter. It is designed to assist in access to the upper urinary tract using standard endoscopic technique for drainage and delivery of gels or fluids. The device is offered without side holes and is available in 5 and 6 Fr. Sizes, which are common to the industry. The catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a quidewire or for the injection of gels or fluids into the urinary tract. The catheter tip is radiused and has a .041" ID that allows for a smooth transition and passage when placed over a guidewire of up to 0.038" inches in diameter that is pre-positioned through the urological tract. The MINNOW Ureteral Catheters are packaged with a standard Touhy-Borst adapter that allows for injection or aspiration of fluids, but removable to allow for scope exchange without having to remove the catheter. The MINNOW Ureteral Catheters are available in 5 and 6 French (Fr) diameter, with a catheter length of 70 centimeters (cm).