FOOTSWITCH, EPK
N/A - OS-A106
Device Description
An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.
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: PEA
Device Name: Endoscope, Accessories, Image Post-Processing For Color Enhancement
Device Class: 2
Physical State: The system consists of flexible and/or rigid scope(s), light source(s), video processor and display.
Definition: Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Image enhancement using image post-processing algorithms of the received white light image with the goal of enhancing visualization of suspicious images seen on white light.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Limited to endoscopic systems for observation of the gastro-urological tract.
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 04961333245239
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