Duns Number:544559614
Device Description: The self-adhesive electrode is intended to be used to apply electrical stimulation current The self-adhesive electrode is intended to be used to apply electrical stimulation current to the patient's skin.Example electrical stimulations for current applications of the electrodes are:TENS (Transcutaneous Electrical Nerve Stimulation)EMS (Electrical Muscular Stimulation)
Catalog Number
-
Brand Name
AUVON
Version/Model Number
EB1548021
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
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
5acdf6d6-8afb-4de8-a464-80461d866e8f
Public Version Date
January 18, 2022
Public Version Number
2
DI Record Publish Date
January 05, 2022
Package DI Number
16971292002298
Quantity per Package
40
Contains DI Package
06971292002291
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 99 |