KEYBOARD FOR EPK
N/A - OS-A94
Device Description
A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an endoscopic device (e.g., endoscope video camera) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.
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 Identifiers
Device Id: 04961333245284
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
