Duns Number:080186051
Device Description: CT Syringe (2) with Y-Tubing and Handi-Fil Straws; fits injector: OptiVantage
Catalog Number
-
Brand Name
LF
Version/Model Number
844022
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
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
69d30b65-2f52-4f5a-97e2-6a1c586c1ab7
Public Version Date
January 05, 2022
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
20746190002311
Quantity per Package
20
Contains DI Package
10746190002314
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |