Duns Number:002111896
Catalog Number
A10097
Brand Name
VersaTrode™
Version/Model Number
A10097
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 24, 2019
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
b52778ab-9463-4c9d-a509-f76440283918
Public Version Date
May 27, 2019
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
20813150021221
Quantity per Package
60
Contains DI Package
10813150021224
Package Discontinue Date
May 24, 2019
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 |