Duns Number:039576871
Device Description: SUBDURAL GRID ELECTRODE, 2MM, STAINLESS STEEL, 32 CONTACT, 2X16, SMOOTH, INLINE CONNECTOR SUBDURAL GRID ELECTRODE, 2MM, STAINLESS STEEL, 32 CONTACT, 2X16, SMOOTH, INLINE CONNECTOR, 2 EXIT, ALL CONTACTS NUMBERED
Catalog Number
-
Brand Name
CORTAC
Version/Model Number
2111-32-116
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
K845035
Product Code
GYC
Product Code Name
Electrode, Cortical
Public Device Record Key
9132329e-6ce6-4c8c-86f7-a8909eabc947
Public Version Date
July 06, 2021
Public Version Number
1
DI Record Publish Date
June 28, 2021
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 | 673 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8273 |
| U | Unclassified | 1188 |