Duns Number:606234730
Device Description: Box of 50 pairs (1-right & 1-left per pair) of electrodes for use with the RETeval visual Box of 50 pairs (1-right & 1-left per pair) of electrodes for use with the RETeval visual electrophysiology system.
Catalog Number
Sensor Strips
Brand Name
RETeval™
Version/Model Number
Sensor Strips
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142567,K142567
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
84e404fc-318e-41fa-94cf-e111ae393d1b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 04, 2016
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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 37 |