Address:5 Hanofar Str.,Raanana Central,IL
Device Description : The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning.
Device Class : 2
Duns Number: 649905544
Premarket Exempt : No
Prescription Use : Yes
Device Description : The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning.
Device Class : 2
Duns Number: 649905544
Premarket Exempt : No
Prescription Use : Yes
Device Description : The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning.
Device Class : 2
Duns Number: 649905544
Premarket Exempt : No
Prescription Use : Yes
Device Description : The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning.
Device Class : 2
Duns Number: 649905544
Premarket Exempt : No
Prescription Use : Yes
Device Description : The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning.
Device Class : 2
Duns Number: 649905544
Premarket Exempt : No
Prescription Use : Yes
Device Description : The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning.
Device Class : 2
Duns Number: 649905544
Premarket Exempt : No
Prescription Use : Yes
Device Description : The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC (also The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC (also "SPARKC") air control system which controls inflation and deflation of the G-EYE® balloon. The G-EYE® balloon is inflated using ambient air and controlled by the SPARKC via a foot pedal or a remote panel.
Device Class : 2
Duns Number: 649905544
Premarket Exempt : No
Prescription Use : Yes
Device Description : An inflation system providing controlled inflation and deflation of the NaviAid™ An inflation system providing controlled inflation and deflation of the NaviAid™ AB balloon.
Device Class : 2
Duns Number: 649905544
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure positioning of a standardendoscope in the small intestine. It enables the advancement of a standard endoscope into the small intestinewhile utilizing the existing endoscope optics and utilities.The NaviAid™ AB Device is comprised of a balloon catheter (‘AB Disposable’) which is inserted through theinstrument channel of the endoscope, similarly to other endoscopic accessories, and a supporting single balloonair supply and control unit – NaviAid™ SPARK (‘SPARK’) for providing controlled inflation and deflation of theballoon.The NaviAid™ AB Device is indicated for use in adults and adolescent population.
Device Class :
Duns Number: 649905544
Premarket Exempt : No
Prescription Use : Yes
Device Description : Device Description (max 2000 characters):The NaviAid™ AB device is an accessory Device Description (max 2000 characters):The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure positioning of a standardendoscope in the small intestine. It enables the advancement of a standard endoscope into the small intestinewhile utilizing the existing endoscope optics and utilities.The NaviAid™ AB Device is comprised of a balloon catheter (‘AB Disposable’) which is inserted through theinstrument channel of the endoscope, similarly to other endoscopic accessories, and a supporting single balloonair supply and control unit – NaviAid™ SPARK (‘SPARK’) for providing controlled inflation and deflation of theballoon.The NaviAid™ AB Device is indicated for use in adults and adolescent population.
Device Class :
Duns Number: 649905544
Premarket Exempt : No
Prescription Use : Yes