Duns Number:268009609
Device Description: SUBDURAL ELECTRODE WITH CONNECTION CABLE, GRID, 2x6 CONTACTS
Catalog Number
C10-12BIOM
Brand Name
NA
Version/Model Number
INTRAOPERATIVE SUBDURAL ELECTRODE
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
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
K201931
Product Code
GYC
Product Code Name
Electrode, Cortical
Public Device Record Key
649d0456-8c37-47ba-bd1f-49c06db986bf
Public Version Date
January 10, 2022
Public Version Number
1
DI Record Publish Date
January 01, 2022
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 108 |