Duns Number:002111896
Device Description: Disposable ECG Electrodes
Catalog Number
6503189V
Brand Name
TenderTrode Plus™
Version/Model Number
A10058-SRT-EU
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2022
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
e7b91e59-fb9a-4926-8f51-72b006c7bc16
Public Version Date
October 03, 2022
Public Version Number
3
DI Record Publish Date
September 17, 2019
Package DI Number
50009336009928
Quantity per Package
60
Contains DI Package
10009336009920
Package Discontinue Date
October 01, 2022
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 |