DEVICE: GreenEgg (00860001161618)

Device Description: DEVICE DESCRIPTION The GreenEgg™ is a sterile, single-use hand held, non-powered pelvic manipulator used for surgical manipulation and transillumination of the rectum and/or vagina. The 30mm diameter polymer tip fluoresces when viewed under a near infrared system PACKAGING CONTENTS A single GreenEgg™ device is CSR wrapped and placed inside a Tyvek header bag in sterile fashion. INDICATIONS FOR USE The EndoGlow GreenEgg™ manipulator is indicated to provide manipulation of the vaginal or rectum during minimally invasive surgical procedures. When viewed with the NIR camera system of a laparoscope or surgical robot, the GreenEgg™ will fluoresce providing transillumination DIRECTIONS FOR USE Confirm exp date. Remove bag from box, open the bag using sterile technique. Transfer the contents of the bag (CSR blue wrapped GreenEgg™ manipulator) to sterile field Once introduced to the field, the CSR wrap can be removed from the device and discarded. The GreenEgg™manipulator is ready for use Insert the GreenEgg™ manipulator into the vagina or rectum and proceed with surgical procedure CONTRAINDICATIONS The GreenEgg™ is a nonpowered, handheld manipulator, do not use it outside of standard surgical protocol or techniques WARNINGS Contents supplied sterile. Do not use if sterile barrier is damaged Do not use the GreenEgg™ if the device has been opened or damaged CAUTION U.S. Federal law restricts this device to sale by or on the order of a physician STORAGE Store at room temp, avoid extreme temps DISPOSAL Dispose of in accordance with all applicable Federal, State, and local Medical/ Hazardous waste practices REUSE PRECAUTION STATEMENT For single use only: Do not reuse, re-process or re-sterilize. Do not reuse, reprocess, or re-sterilize. Attempting to re-sterilize and reuse the product may diminish its intended performance in transilluminating tissue, reducing its effectiveness. To ensure optimal results and patient safety, a new product must be used for each procedure.