Duns Number:039576871
Device Description: Depthalon Electrode, Platinum, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording l Depthalon Electrode, Platinum, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording length, Miniconnector, 1 exit, 2 leads, 2 exits
Catalog Number
-
Brand Name
Depthalon
Version/Model Number
2104-08-16-004
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
713dc06a-ab2b-441e-850e-92355cdd46c4
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 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 |