Duns Number:938215568
Device Description: DYEVERT™ CONTRAST MODULATION SYSTEM
Catalog Number
-
Brand Name
DyeVert
Version/Model Number
AA-HV
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 21, 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
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
cd2db9cd-eea0-40ff-9059-7c63e3e9eba3
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. | 21 |