Duns Number:989925396
Device Description: Flexible EEG Cable Two-Piece, 48 Pins, 3 Cam Lock Connector. The Integra® Flexible EEG Cab Flexible EEG Cable Two-Piece, 48 Pins, 3 Cam Lock Connector. The Integra® Flexible EEG Cables are accessories for the Integra Electrodes (Integra Cortical Strip and grid Electrodes and Integra Depth Electrodes) which are intended for the recording of EEG signals at the surface or subsurface levels of the brain.
Catalog Number
FLEX48C3
Brand Name
Integra®
Version/Model Number
FLEX48C3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
-
Product Code
IKD
Product Code Name
CABLE, ELECTRODE
Public Device Record Key
9c6954ee-0b36-4483-8ba8-809734d3734f
Public Version Date
October 26, 2022
Public Version Number
3
DI Record Publish Date
October 17, 2018
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |
| U | Unclassified | 114 |