Duns Number:927071162
Device Description: ST50R Tens Electrode - Premium 48mm Round Stimulating Electrodes
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
ST50R Tens Electrode
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)
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
60665dc0-0b7d-4ff9-8780-2f42afc9996c
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
August 03, 2016
Package DI Number
30817325020627
Quantity per Package
5
Contains DI Package
20817325020620
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 309 |