Duns Number:080186051
Device Description: Dual CT Syringe with Y-Tubing (60”/1500 mm) and Filling Spikes; for use with OptiVantage
Catalog Number
-
Brand Name
LF
Version/Model Number
844022P
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
d5868d79-6a13-4ab0-859c-6a3df65233bf
Public Version Date
January 05, 2022
Public Version Number
2
DI Record Publish Date
January 29, 2021
Package DI Number
20746190004254
Quantity per Package
20
Contains DI Package
10746190004257
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 |