Duns Number:002449593
Device Description: Signagel Electrode Gel, 250 gram tube
Catalog Number
15-25
Brand Name
SIGNAGEL
Version/Model Number
ELECTRODE GEL
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GYB
Product Code Name
Media, Electroconductive
Public Device Record Key
821d71a5-8dee-4988-91ed-50b12401c2a8
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
December 19, 2016
Package DI Number
20855683006214
Quantity per Package
6
Contains DI Package
10855683006217
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |