Duns Number:066689993
Device Description: TENSRX SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 520/CASE
Catalog Number
NPPELE615
Brand Name
TENSRX
Version/Model Number
ELE615
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"
-
For Single-Use
-
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
f5f7b4b4-d89b-4dd9-986a-a74af77d45c5
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
October 13, 2016
Package DI Number
10815991020350
Quantity per Package
65
Contains DI Package
00815991020353
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |