Instrumentation Difra 22221

GUDID B516222210

The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II

Instrumentation Difra SA

Electronystagmograph Electronystagmograph

• Primary Device ID: B516222210
• NIH Device Record Key: 11e18246-6439-4d10-a521-4e8a4e4dadb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrumentation Difra
• Version Model Number: NysStar II with VOR
• Catalog Number: 22221
• Company DUNS: 370173410
• Company Name: Instrumentation Difra SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B516222210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070670

FDA Product Code

• GWN: Nystagmograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-19

On-Brand Devices [Instrumentation Difra]

• B516222210: The videonystagmography performed by a camera and infra red light measures and records the eye m
• B51622186: The VISIOBOX allows to stimulate visually the patient for the diagnosis of its vestibular system
• B516221340: The videonystagmography performed by a camera and infra red light measures and records the eye m
• B516221280: The videonystagmography performed by a camera and infra red light measures and records the eye m
• B51622092: The VIDEOSTAR is a digital videoscopy system. It is designed to allow qualified personnel to vis
• B51622090: The videonystagmoscope transcribes the image of the patient's eye on a computer screen. The VIDE
• B51617553: The air caloric stimulator is a device that delivers a stream of air to the ear canal at control
• B51617550: The water caloric stimulator is a device that delivers a stream of water to the ear canal at con
• B51617485: The air caloric stimulator is a device that delivers a stream of air to the ear canal at control
• B51617481: The air caloric stimulator is a device that delivers a stream of air to the ear canal at control
• B51617473: The water caloric stimulator is a device that delivers a stream of water to the ear canal at con
• B516227090: The videonystagmography performed by a camera and infra red light measures and records the eye m
• B516221860: The VISIOBOX allows to stimulate visually the patient for the diagnosis of its vestibular system
• B516175530: The air caloric stimulator is a device that delivers a stream of air to the ear canal at control
• B516175500: The water caloric stimulator is a device that delivers a stream of water to the ear canal at con
• B516174850: The air caloric stimulator is a device that delivers a stream of air to the ear canal at control
• B516174810: The air caloric stimulator is a device that delivers a stream of air to the ear canal at control
• B516174730: The water caloric stimulator is a device that delivers a stream of water to the ear canal at con
• B516223150: The Ideas III is an Electronystagmography (ENG) system. Electronystagmography measures eye movem