Duns Number:080186051
Device Description: Angio / CT Syringe with Handi-Fil Straw; fits injectors: OptiStat and Angiomat 6000
Catalog Number
-
Brand Name
LF
Version/Model Number
600172
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 14, 2021
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
6b9543e8-6799-49fb-b75a-ee2d85d01741
Public Version Date
January 05, 2022
Public Version Number
6
DI Record Publish Date
September 09, 2016
Package DI Number
20746190002014
Quantity per Package
50
Contains DI Package
10746190002017
Package Discontinue Date
December 14, 2021
Package Status
Not 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 |