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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.
Endoglow, LLC
EP1000-30
In Commercial Distribution
- 00860001161618 ()
- 10860001161615 ()
- Length: 12.5 Inch
- Outer Diameter: 30 Millimeter
EP1000-30
- Colonic bougie
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