Duns Number:126290993
Device Description: 40 electrodes, Sticky Pad™ Surface Electrodes for NCV, Ground Pad
Catalog Number
-
Brand Name
Rhythmlink®
Version/Model Number
NCVG40L-1.0
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"
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
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
54853f24-038a-4fa8-8557-7d04525c1dbb
Public Version Date
September 27, 2022
Public Version Number
1
DI Record Publish Date
September 19, 2022
Package DI Number
20816312026287
Quantity per Package
40
Contains DI Package
10816312026280
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Product Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 453 |