Duns Number:080930531
Device Description: Iontophoresis Drug Delivery Large Kit Electrodes - 4.0 cc, 4mA-min incl. buffered return 3 Iontophoresis Drug Delivery Large Kit Electrodes - 4.0 cc, 4mA-min incl. buffered return 3.5" x 3.5"
Catalog Number
-
Brand Name
Ionto Plus Large Electrode
Version/Model Number
201-453
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EGJ
Product Code Name
Device, Iontophoresis, Other Uses
Public Device Record Key
827ab6fa-81ae-498e-99c5-0656eab38550
Public Version Date
October 29, 2018
Public Version Number
1
DI Record Publish Date
September 26, 2018
Package DI Number
80092237901775
Quantity per Package
24
Contains DI Package
30092237901770
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 47 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 449 |