Duns Number:039576871
Device Description: CORTAC GRID ELECTRODE, PLATINUM, 64 MACRO CONTACTS, 8x8 SMOOTH IOM CONNECTOR, 1 EXIT, 4 LE CORTAC GRID ELECTRODE, PLATINUM, 64 MACRO CONTACTS, 8x8 SMOOTH IOM CONNECTOR, 1 EXIT, 4 LEADS
Catalog Number
-
Brand Name
CORTAC
Version/Model Number
2110-64-146
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
K082474
Product Code
GYC
Product Code Name
Electrode, Cortical
Public Device Record Key
ff7ca567-5e60-4e1a-9877-ded0795ae95a
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 2020
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 |