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 2 Cam Lock cylindrical Connectors. It has 16 gold plated connector pins corresponding to the electrode Contacts, to be plugged into the corresponding EEG Monitor input channels. It features 2 intermediate connectors at 30cm allowing an easy disconnection if desired.
Catalog Number
-
Brand Name
Integra®
Version/Model Number
ECCFS16
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"
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
50b5e99a-3808-4abe-8987-27c5fcdc4459
Public Version Date
December 20, 2018
Public Version Number
3
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 |