Duns Number:173358318
Device Description: 2.0" X 2.0" Square electrode patch in pouch of 4 each electrodes.
Catalog Number
-
Brand Name
TPWT4-2
Version/Model Number
TENS
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
Yes
Prescription Use (Rx)
-
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
a6ff1db9-9992-4f65-a585-e23506087aa5
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
October 03, 2016
Package DI Number
30816625020122
Quantity per Package
4
Contains DI Package
10816625020128
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 19 |