Duns Number:531408342
Device Description: The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring o The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
Catalog Number
-
Brand Name
Integra®
Version/Model Number
EDSEP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 18, 2019
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"
Yes
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
K961942
Product Code
GZL
Product Code Name
ELECTRODE, DEPTH
Public Device Record Key
9e398664-1835-4f45-b167-7f64d8be3dd4
Public Version Date
December 02, 2019
Public Version Number
5
DI Record Publish Date
August 08, 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 |