Duns Number:531408342
Device Description: The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cor The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
Catalog Number
-
Brand Name
Auragen™
Version/Model Number
AU1X8PN
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"
Yes
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
K082250
Product Code
GYC
Product Code Name
ELECTRODE, CORTICAL
Public Device Record Key
d14ac60f-bd49-4214-9f6f-893fcc68abaa
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 08, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |