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The Dornier Hoover Negative Pressure Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

The Dornier Hoover Negative Pressure Access Sheath is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. It is for the passage of endoscopes and other urological devices for Ureteroscopy and used for the treatment of stones and for the removal of foreign bodies in the urinary tract. The packaged product includes a Hydrophilic-coated Dilator with a locking mechanism and a Hydrophilic- coated guide sheath with joint. The guide sheath is fitted with a Y connector on the Y connector is bifurcated straight tube and oblique tube. One segment of the Y connector is straight and is contiguous with the sheath. The other is constructed in an oblique angle with a longitudinal pressure control vent. The oblique tube is to be connected to a negative pressure aspirator with clear tube or alternatively, connected to a specimen collector then onto a negative pressure aspirator, then to collect stones or foreign bodies during the endoscopic procedure. A dilator is included for the insertion of the dilator is radiopaque and is fitted with a hand buckle on the proximal end. The dilator can be locked to the proximal end of the straight tube using a locking mechanism. The Dornier Hoover Neqative Pressure Access Sheath is reinforced with a stainless-steel coil, constructed of a medical grade thermoplastic elastomer. All colorants used are compliant with FDA standards. The device is offered of inner diameter in French size 10Fr, 12Fr and length 40cm, 50cm. The device is supplied sterile and intended for single use only. The Dornier Hoover Neqative Pressure Access Sheath has six different models. The structural composition and materials of the different models are identical. The only difference is in dimension including inner diameter, and length.

The Trident Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

The Trident Mobile Fluoroscopy System is a mobile Image Intensified Fluoroscopic X-ray unit with a flat panel image receptor system. The Trident Mobile Fluoroscopy System consists of the following components: an X- ray generator and tube housing and a flat panel detector. An X-ray cabinet contains system elements such as the X- ray generator, power electronics for the imaging chain. The system offers an optional monitor for viewing the captured images. The X-Ray Generator is located in the base of the C-Arm. High voltage is carried to the X-Ray tube across a set of cables and the X-Ray tube emits the X-Rays that are directed toward the control of the operator. The X-Rays pass through the patient and are captured by the flat panel image detector (FPD). The flat panels used in the Trident Mobile Fluoroscopy System are Varex models 3030DX or 2121DXV. This Varex series have been used in similar cleared devices (K192541, K220871). The Varex flat panel system used in the Trident uses Cesium lodide as the image scintillator which is identical to that used in the reference device (K220871). These flat panel models differ only in the dimensions of the image receptor. FPD images are processed and can be displayed on the optional image monitor located on the Workstation. The Physician or system operator can view the images as they are displayed on the attached monitor or they may also choose to store the images for later review via the connection to the hospital DICOM system. The C-Arm is designed to move into the required positions to allow for proper x-ray locations in relation to the patient for the procedure that is being performed. These procedures can be performed with or without a patient table. In order to accomplish this, the system is designed with the ability to rotate/swivel to obtain different appropriate viewing angles. The systems movement is manually adjusted with the exception of the z-axis. This is motorized with the controls on the C-arm. The release of x-ray is controlled using a footswitch and/or a hand controller.

The Delta III Pro Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Pro Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III is composed of the following modules: - . Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; - Patient Table: . - Control Desk/Image Storage (UIMS). . The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service. The therapy and X-ray C-arm house the shock wave source ("EMSE") and the complete X- ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, a flat panel image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones. The Delta III Pro's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-rav control and image handling.

The Dornier Nautilus is an image intensified, fluoroscopic x-ray system that is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Dornier Nautilus is an Image Intensified Fluoroscopic X-ray System with a flat panel image receptor system. The Nautilus consists of the following components: an X- ray generator and tube housing, flat panel detector, monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics for the imaging chain. The Dornier Nautilus is a radiographic and fluoroscopy examination table with the X-ray tube housing mounted under the table on a fixed arm. A flat panel detector is mounted above the patient table. The flat panel used is a Varex model 4343DXV. These Varex 4343 series have been used in similar cleared devices (K192541). The Varex flat panel system uses Cesium lodide as the image scintillator which is identical to that used in the predicate device. While the X-ray tube and detector are fixed in their positions relative to each other when the system is in use, the table top and X-ray/detector unit can be moved in a variety of planes to position the patient in the desired imaging position. The captured images are processed and can be stored in the users DICOM system.

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 Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; Patient Table; Control Desk/Image Storage (UIMS).

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).