Duns Number:483267576
Device Description: The ERG-Jet is a contact lens for performing an electroretinogram, or ERG, provocated by l The ERG-Jet is a contact lens for performing an electroretinogram, or ERG, provocated by light stimulation of the retina in either humans or animals. The electrode is made of a gold ring just a few angstroms (10-10 meter) thick, which can be safely placed in contact with the cornea using a viscous conductive liquid.
Catalog Number
-
Brand Name
ERG-Jet
Version/Model Number
F06
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
HLZ
Product Code Name
Electrode, Corneal
Public Device Record Key
1e11510e-4d78-4d52-a184-e039bfb2bffd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 10, 2016
Package DI Number
EFABF061
Quantity per Package
50
Contains DI Package
EFABF062
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |