Duns Number:135741127
Device Description: Electrodes 2.0"x4.0" Blue Gel Adhesive For Sensitive Skin (1 Pack = 4 Electrodes Per Pack Electrodes 2.0"x4.0" Blue Gel Adhesive For Sensitive Skin (1 Pack = 4 Electrodes Per Pack)
Catalog Number
ProM-034
Brand Name
Gentle Patch
Version/Model Number
ProM-034
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)
Yes
Kit
-
Combination Product
Yes
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
78f23cc6-c3cd-4522-8cc5-86e3dc8e6646
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
August 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |