Duns Number:531408342
Device Description: The OCS2PND is a bipolar stimulating probe for cortical stimulation with malleable tips fo The OCS2PND is a bipolar stimulating probe for cortical stimulation with malleable tips for precise localization. The probe has 2 mm diameter polished balls, spaced 5 mm apart, at the tip of the stimulator probe. It has a 310 cm cord with two electrically shrouded banana plugs for attachment to the OCS2 Ojemann Cortical Stimulator. It is reusable, is supplied non-sterile and must be sterilized before use.
Catalog Number
-
Brand Name
Integra®
Version/Model Number
OCS2PND
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
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
K924226
Product Code
GYC
Product Code Name
ELECTRODE, CORTICAL
Public Device Record Key
76dc736d-7b13-4f13-85f4-4c1ee7191abc
Public Version Date
December 20, 2018
Public Version Number
4
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 |