Duns Number:080186051
Device Description: MR Syringe with Lateral Flow Needle; fits injectors: OptiStar Elite and OptiStar LE
Catalog Number
-
Brand Name
LF
Version/Model Number
801801
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
3d7ae8b4-b0f2-43de-9be7-9311815f3ba5
Public Version Date
January 05, 2022
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
30746190002219
Quantity per Package
5
Contains DI Package
20746190002212
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 |