AccessGUDID - DEVICE: Instrumentation Difra (B516220920)

GUDID

Device Identifier (DI) Information

Brand Name: Instrumentation Difra
Version or Model: VIDEOSTAR II
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22092
Company Name: Instrumentation Difra SA

Primary DI Number: B516220920
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 370173410 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWN	Nystagmograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: be8e1389-6f3c-47a6-9e34-781859d4bb2f
Public Version Date: June 26, 2020
Public Version Number: 1
DI Record Publish Date: June 18, 2020