Duns Number:370173410
Device Description: VIDEOSTAR I is a monocular videonystagmoscope device. It transcribes the image of the pati 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.
Catalog Number
22090
Brand Name
Instrumentation Difra
Version/Model Number
VIDEOSTAR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GWN
Product Code Name
Nystagmograph
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |