Duns Number:060121928
Device Description: Norco Buffered Iontophoretic Delivery Kit- Large Sample Pack (2)
Catalog Number
-
Brand Name
Norco Iontophoresis Large Sample
Version/Model Number
SA89252B
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"
Yes
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
751f63e5-5e2c-4dea-800b-6ea92c0e4194
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 01, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 18 |