Duns Number:080557421
Device Description: Transcutaneous electrical stimulation electrode, Square, 50x50mm, Cloth material
Catalog Number
5050-WCSD
Brand Name
Medical Science Products
Version/Model Number
5050-WCSD
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)
-
Over the Counter (OTC)
Yes
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
9eaab3f1-2e9f-47e7-8c26-b6647a85a2ae
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
October 19, 2017
Package DI Number
10851610008026
Quantity per Package
400
Contains DI Package
00851610008029
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |