VIDEO NASOLARYNGOSCOPE (FOR VIVIDEO) (USED)

VIDEO NASOLARYNGOSCOPE (FOR VIVIDEO) (USED)
VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE - VNL9-CP

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the larynx. It is inserted into the body through the mouth during laryngoscopy. Anatomical images are transmitted to the user by a video system at the distal end of the endoscope with the images showing on a monitor. This device is commonly used to evaluate or operate on laryngeal strictures, foreign bodies, or neoplasms; it is not intended for intubation of an artificial airway. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Liquid Chemical
• High-level Disinfectant

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 Id: 04961333240463

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