Xenon Lamp

Xenon Lamp - MD-631

A mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 04953170064494

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