Duns Number:531408342
Device Description: The female electrode connecting cable is a reusable device used to connect the Integra® Co The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG monitor through 6 Cam Lock cylindrical Connectors. It has 48 gold plated connector pins corresponding to the electrode Contacts, to be plugged into the corresponding EEG Monitor input channels.It features 6 intermediate connectors at 30cm allowing an easy disconnection if desired.
Catalog Number
-
Brand Name
Integra®
Version/Model Number
ECCFS48
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2019
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"
Yes
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
b866a8ad-171f-4736-92f8-a394866fb850
Public Version Date
September 24, 2019
Public Version Number
4
DI Record Publish Date
August 12, 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 |