Duns Number:132515441
Device Description: MR Syringe Dual Pack (Includes; 2-60mL Syringes, 2-Lateral Flow Needle Spike, and 1-96" Y- MR Syringe Dual Pack (Includes; 2-60mL Syringes, 2-Lateral Flow Needle Spike, and 1-96" Y-Line with 2 Check Valves)
Catalog Number
C853-0078
Brand Name
Coeur
Version/Model Number
C853-0078
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
7576a883-9007-471f-8560-20c179634ce1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 06, 2016
Package DI Number
M297700786
Quantity per Package
50
Contains DI Package
M297700780
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |