EVIS EXERA COLONOVIDEOSCOPE - OLYMPUS CF TYPE 2T160L
Device Description
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to a monitor for viewing by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Ethylene Oxide
- High-level Disinfectant
Product Codes
Code: FET
Device Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class: 2
Physical State: May include: ccd camera, monitor, other software or hardware associated with video equiptment, and components from other regulations, such as a pump.
Definition: To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Inserted through endoscope.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: various body cavities, hollow organs, and canals in gi and gu tract.
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 04953170307652
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A