Duns Number:080930531
Device Description: Iontophoresis Drug Delivery Electrodes
Catalog Number
-
Brand Name
Ionto Plus Medium, Box of 12
Version/Model Number
201-449
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
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)
-
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
e33cbc6f-c100-433a-a1b5-adca8bada228
Public Version Date
December 31, 2018
Public Version Number
4
DI Record Publish Date
April 22, 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 | 47 |
2 | A medical device with a moderate to high risk that requires special controls. | 449 |