Duns Number:002111896
Device Description: Electrode
Catalog Number
2106919-001
Brand Name
GE Healthcare
Version/Model Number
2106919-001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 12, 2021
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"
Yes
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
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
fccf6fb2-ff56-4750-976b-eae23dd53005
Public Version Date
July 12, 2021
Public Version Number
3
DI Record Publish Date
April 12, 2018
Package DI Number
50009336009188
Quantity per Package
600
Contains DI Package
10009336009180
Package Discontinue Date
July 12, 2021
Package Status
Not 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 | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 269 |
| 3 | A medical device with high risk that requires premarket approval | 1 |