VIDEO PROCESSOR (REFURBISHED)
VIDEO PROCESSOR - EPM-3500
Device Description
An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
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 Identifiers
Device Id: 04961333232628
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