Duns Number:002449593
Device Description: Redux Electrolyte Gel, 4 oz tube
Catalog Number
65-04
Brand Name
REDUX
Version/Model Number
ELECTROLYTE 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
841d7ed6-44f0-4f38-bfd5-b0c0dc058a5b
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
December 19, 2016
Package DI Number
20855683006382
Quantity per Package
5
Contains DI Package
10855683006385
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 |