Duns Number:009831413
Device Description: Gentle Stim Ionto Buffered Iontophoresis Electrode Treatment Kit Latex fee, Non-Sterile di Gentle Stim Ionto Buffered Iontophoresis Electrode Treatment Kit Latex fee, Non-Sterile disposable single use only medium square
Catalog Number
P850325
Brand Name
Pro Advantage Buffered Iontophoresis Electrode Treatment Kit
Version/Model Number
P850325
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
f5b5f853-989f-456b-b0e1-106c27b7623e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 13, 2017
Package DI Number
M220P8503255
Quantity per Package
10
Contains DI Package
M220P8503252
Package Discontinue Date
-
Package Status
-
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |