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The Intermittent Urethral Catheters are sterile, single-use, flexible tubular devices that are to be inserted through the urethra and used to pass fluids to or from urinary tracts.

The Intermittent Urethral Catheters will be offered in two rne Incernitions Both styles will be offered with or without Catheter. The Standard Urethral Catheter will be hydrophilic coating. offered in three tip configurations.

Stenting: Esophaqeal stenoses (strictures), such as stenting refractory beniqn strictures and/or malignant strictures Esophageal-respiratory-fistula Maintaining esophagus lumen patency in esophageal strictures caused by intrinsic or extrinsic tumors

The Rüsch Polyflex Stent for the Esophagus with Introducer System consists of the Polyflex Stent, Introducer Sleeve, Stent Loader, Insertion Tube with Dilator, Soft Positioner, Stopper and Stent Clamp.

The Rüsch Guided Cholangiography Catheter is intended for intraoperative cholangiography during laparoscopic cholecystectomy.

The Rüsch Guided Cholangiography Catheter is a sterile, singleuse device that consists of the following components: - 10Fr, 30cm, Silicone-Sealed, Curved Polyurethane Guide Catheter . with Guide Handle - 4Fr, 120cm, Curved, Polyvinylchloride Cystic Duct Catheter with ● Luer-Lock Syringe Connector 5mm OD, 27cm length, Silicone-Sealed Polyurethane Introduction Tub The Guide Catheter is provided with a curved tip and a guide handle. The tip is directable toward the desired site by turning the guide handle thus facilitating placement. The direction of the tip is always known as it is in direct relation to the direction flange on the quide handle. The Cystic Duct Catheter provides centimeter markings at the distal tip to aid in placement. Each Rüsch Guided Cholangiography Catheter will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, in a clear poly pouch with a medical paper seal. Each device will be individually labeled. The device will then be packaged in a labeled outer cardboard carton. The device will be marketed 5 units per box.

The Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless are intended for airway management of tracheostomized patients.

The Rüsch Crystal Clear Tracheostomy Sets will be offered in two (2) versions - Cuffed and Cuffless. Descriptions are: Rüsch Crystal Clear Tracheostomy Set, Cuffed: The Rüsch Crystal Clear Tracheostomy Set, Cuffed consists of a polyvinylchloride (PVC) tracheostomy tube with high volume/low pressure cuff, pilot balloon and tapered tip to facilitate insertion, a PVC flexible neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory. This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube. Rüsch Crystal Clear Tracheostomy Set, Cuffless: The Rüsch Crystal Clear Tracheostomy Set, Cuffless consists of a polyvinylchloride (PVC) tracheostomy tube with a tapered tip to facilitate insertion, a PVC flexible flange with a PVC turn lock fastener neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory. This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube. Each Rüsch Crystal Clear Tracheostomy Set, Cuffed and Cuffless will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, inside a protective inner pouch in a blister pack sheet with a Tyvek paper seal to provide a sterility barrier. Each pack will be individually labeled. The device will then be packaged, five units per carton, in a labeled outer cardboard carton. The inner cannulae will be marketed separately as accessories under separate part numbers.

The Rüsch Microlaryngeal Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management during laryngeal procedures.

The Rüsch Microlaryngeal Tube will be offered in three (3) sizes - 4.0mm, 5.0mm and 6.0mm ID. The devices will have a low-pressure/high volume cuff, inflated via a luer activated valve. A pilot balloon will be provided to give a visual indication of cuff status. The Rüsch Microlaryngeal Tube consists of a clear, implant-tested tracheal tube with a radiopaque stripe. The main tube is graduated with multiple centimeter markings to facilitate determination of intubated length.

The Rüsch Edgar Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management. The integral instillation system is indicated for drug instillation by the endobronchial route, anesthetic administration and gas monitoring.

The Rüsch Edgar Tube will be offered in the Magill pattern in two (2) versions - cuffed and uncuffed. Cuffed versions will have a low-pressure/high volume cuff, inflated via a luer activated valve. A pilot balloon will be provided to give a visual indication of cuff status. The Rüsch Edgar Tube consists of a clear endotracheal tube with a radiopaque stripe. The main tube is graduated with multiple centimeter markings to facilitate determination of intubated length. The instillation lumen is connected to a luer lock connector with cap by a tube that is color coded to prevent confusion with the cuff inflation line. The Rüsch Edgar Tube will be available in a variety of sizes ranging from 2.5mm - 6.0mm uncuffed and 6.5mm - 10.0mm cuffed. Both versions will be available in 0.5mm increments.

The Rusch TracheoFix Set (TFS) is a single patient disposable tracheostomy tube for airway management of tracheostomized patients.

TracheoFix Sets will be offered in two (2) versions - Cuffed and Uncuffed. Descriptions are as follows: Rüsch TracheoFix Set, Cuffed: The Rüsch TracheoFix Set, Cuffed consists of a polyvinylchloride (PVC) outer tube with low pressure cuff and pilot balloon, a PVC flexible flange with a PVC turn lock fastener. The flange on this device is not adjustable. In addition, the set will also include a polyethylene cannula with standard taper and a replacement cannula which will be offered separately as an accessory, a polyethylene introducer, a standard nylon connector, a Velcro head band also offered separately as an accessory, an ABS phonation valve, an ABS cough cap and an ABS sealing cap. This set will be offered in a variety of sizes from 7.0mm, to 11.0mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the outer tube. Rüsch TracheoFix Set, Uncuffed: The Rüsch TracheoFix Set, Uncuffed consists of a polyvinylchloride (PVC) outer tube, a PVC flexible flange with a PVC turn lock fastener. The flange on this device is not adjustable. In addition, the set will also include a polyethylene inner tube with standard taper and a replacement inner tube which will be offered separately as an accessory, a polyethylene introducer, a standard nylon connector, a Velcro head band which will also be offered as an accessory, an ABS phonation valve, an ABS cough cap and an ABS sealing cap. This set will be offered in a variety of sizes from 7.0mm, to 11.0mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the outer tube. Each Rüsch TracheoFix Set, Cuffed and Uncuffed will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, in a clear plastic thermoformed tray with a Tyvek barrier/label. Each pack will be individually labeled. The device will then be packaged in a labeled outer cardboard carton. The device will be marketed one unit per box. The Velcro headband and the inner cannula will be marketed separately as accessories under separate part numbers. Both accessories will be marketed sterile, individually packaqed and labeled, ten (10) units per box .

Aseptic Intermittent Self-Catheterization.

The Rüsch FloNeil (coated, with Water Pack) / Rüsch Flocath IntroGel (uncoated, without Water Pack) - consists of a tubular PVC catheter, a split introducer, a silicone introducer tip. introducer cap, lubrication jelly and a pack of 15ml saline (for FloNeil -coated product) inside a closed urine collection bag.