Duns Number:002449593
Device Description: SIGNACREME ELECTRODE CREME 1/2 GAL BOTTLE.
Catalog Number
17-20
Brand Name
SIGNACREME
Version/Model Number
ELECTRODE CREAM
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
K782055,K782055,K782055
Product Code
GYB
Product Code Name
Media, Electroconductive
Public Device Record Key
3f0e966b-128a-4c4a-accd-602e7afeb385
Public Version Date
October 22, 2018
Public Version Number
4
DI Record Publish Date
July 05, 2017
Package DI Number
20855683006245
Quantity per Package
4
Contains DI Package
10855683006248
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 |