Duns Number:008124539
Device Description: Electrically Conductive Gel (ECG), Conductive, Noncorrosive, Salt & Alcohol Free, Water So Electrically Conductive Gel (ECG), Conductive, Noncorrosive, Salt & Alcohol Free, Water Soluble
Catalog Number
-
Brand Name
Electrically Conductive Gel (ECG)
Version/Model Number
1240
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
K962681,K962681
Product Code
GYB
Product Code Name
Media, Electroconductive
Public Device Record Key
8000eb32-9c67-47c3-af23-2ecaf2ea6851
Public Version Date
February 18, 2021
Public Version Number
1
DI Record Publish Date
February 10, 2021
Package DI Number
00616784124032
Quantity per Package
12
Contains DI Package
00616784124018
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |