Duns Number:529174252
Device Description: 60mL Dual MR Syringe with Single Check Valve Y Tubing (90"/2300mm) and Filling Spikes; 60mL Dual MR Syringe with Single Check Valve Y Tubing (90"/2300mm) and Filling Spikes; fits injectors: OptiStar Elite and OptiStar LE
Catalog Number
801800B
Brand Name
LF
Version/Model Number
200103-A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 9999
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
K151960,K151960,K151960
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
f63d6a5d-4858-496e-8060-fefe297471a2
Public Version Date
June 03, 2021
Public Version Number
4
DI Record Publish Date
March 05, 2021
Package DI Number
26938327906065
Quantity per Package
50
Contains DI Package
06938327906061
Package Discontinue Date
December 31, 9999
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 183 |