Instrumentation Difra

Basic Information

• Brand Name: Instrumentation Difra
• Primary DI: B516220920
• Version / Model: VIDEOSTAR II
• Catalog Number: 22092
• Company Name: Instrumentation Difra SA
• Labeler DUNS: 370173410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-18
• Public Version: 1
• Public Version Date: 2020-06-26
• Public Version Status: New
• Public Device Record Key: be8e1389-6f3c-47a6-9e34-781859d4bb2f

Device Description

VIDEOSTAR II is a binocular freefield videonystagmoscope device. It transcribes the image of both eyes on the computer screen. It helps to asses the reaction of the patient viewing his eyes and its nystagmus during testing. The device consists of a goggle equipped with two cameras and an infrared mirror that enables to record both eye's movement without denying patient's field of view a removable cover to set the patient in total darkness and software running on a computer.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWN	Nystagmograph	Neurology	882.1460	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43114	Posturography system platform	A device that is a component of a balance/mobility management system equipped with built-in sensors, transducer and/or force plates that register movement of the patient when he/she adjusts his/her centre of gravity (COG) alignment according to the doctor's instructions, or, the platform provokes destabilizing perturbations and the output of these movements are measured and recorded to the system computer. It is used, e.g., for motor control test (MCT), posture studies, balance, mobility training, and/or sense of equilibrium studies. The patient will stand on this device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B516220920	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]