Duns Number:830016148
Device Description: Nova Plus® Foam Monitoring Electrode V2237-3, 3/BAG, 200/CASE, 40/PLT
Catalog Number
V2237-3
Brand Name
Nova Plus®
Version/Model Number
V2237-3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 28, 2017
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
77d11363-f6a8-4375-b84f-1e317f5ccf74
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
50707387566727
Quantity per Package
200
Contains DI Package
10707387566729
Package Discontinue Date
September 28, 2017
Package Status
Not 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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |