Duns Number:531408342
Device Description: The electrode connecting cable EDSCF is a reusable device used to connect the Integra® Sph The electrode connecting cable EDSCF is a reusable device used to connect the Integra® Sphenoidal electrodes intended for the recording of EEG signals at the under surface of the temporal lobe, to an EEG monitor.The cable features gold-plated electrodes contact pin at one end and monitor connector contacts on the other end.
Catalog Number
-
Brand Name
Integra®
Version/Model Number
EDSCF
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
7d2aa017-ac9f-4b77-bb3c-bf9f2c4b0b94
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 |