AccessGUDID - DEVICE: Instrumentation Difra (B516220900)

GUDID

Device Identifier (DI) Information

Brand Name: Instrumentation Difra
Version or Model: VIDEOSTAR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22090
Company Name: Instrumentation Difra SA

Primary DI Number: B516220900
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 370173410 *Terms of Use

Device Description: VIDEOSTAR I is a monocular videonystagmoscope device. It transcribes the image of the patient's eye on the computer screen. It helps to asses the reaction of the patient viewing his eye and its nystagmus during testing. The device consists of a goggle that set the camera in front of the patient's eye and allows to occult the patient of the outside, a camera with an infrared lighting and a software running on a computer. The camera is place of the left or the right eye, the other one can either be let free or cover to deny patient's view.

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: 5e1283d4-ef06-431a-9f5c-15909262b7ca
Public Version Date: June 26, 2020
Public Version Number: 1
DI Record Publish Date: June 18, 2020