Duns Number:039576871
Device Description: PLATINUM sEEG ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-ST PLATINUM sEEG ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
Catalog Number
-
Brand Name
sEEG DEPTHALON
Version/Model Number
2102-16-169-NS
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"
-
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
-
Product Code
GZL
Product Code Name
Electrode, Depth
Public Device Record Key
3586b882-bc66-40ef-9cd4-ca78c1673c5a
Public Version Date
August 25, 2020
Public Version Number
1
DI Record Publish Date
August 17, 2020
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 | 673 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8273 |
| U | Unclassified | 1188 |