Duns Number:370173410
Device Description: The VIDEOSTAR is a digital videoscopy system. It is designed to allow qualified personnel The VIDEOSTAR is a digital videoscopy system. It is designed to allow qualified personnel to visualize eye reaction of the patient and record digital video.Freefield videonystagmoscope digital USB2
Catalog Number
22092
Brand Name
Instrumentation Difra
Version/Model Number
VIDEOSTAR II
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
HJJ
Product Code Name
Lens, Fresnel, Flexible, Diagnostic
Public Device Record Key
c4f78d83-ea22-4386-974d-0643082e0ecc
Public Version Date
October 18, 2018
Public Version Number
1
DI Record Publish Date
September 17, 2018
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 |