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The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other structures, and surgically produced cavities using infrared transillumination during laparoscopy, thoracoscopy, or open procedures. The indications for use are detailed below: a. Infrared transillumination of the esophagus to assist in the identification and location of the esophagus and its surrounding tissues during laparoscopic, thoracoscopic, and open procedures; b. Infrared transillumination of the rectum and rectosigmoid to assist in the identification and location of these structures and surrounding tissues during gynecological and colorectal laparoscopic and open procedures; and C. Infrared transillumination of other organs or provide transillumination or illumination to other natural or surgically produced cavities.

The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other structures, and surgically produced cavities using infrared transillumination during laparoscopy, thoracoscopy, or open procedures. The InfraVision™ Bougie is a disposable device ranging in diameters from 13 Fr to 60 Fr, all having bougie sheath lengths of 80 cm. The overall length of the Infra Vision™ Bougies is 250 cm. The Infra Vision™ Bougie has a translucent tip that is either tapered or rounded in shape and varies in length.