Duns Number:053824652
Device Description: 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total).A revolutionar 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total).A revolutionary electrode designed especially for use with the Myomonitor and BNS-40 unit.
Catalog Number
-
Brand Name
Myotrode SG Solid Gel TENS Electrodes
Version/Model Number
4300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K040400,K040400,K040400
Product Code
NUW
Product Code Name
Stimulator, Muscle, Powered, Dental
Public Device Record Key
be44822d-8aab-4637-ac8d-50f02e32dbdc
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 19, 2016
Package DI Number
D79243003
Quantity per Package
20
Contains DI Package
D79243001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |