Duns Number:132515441
Device Description: MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 1-65mL Syringe, 1-115mL Syr MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 1-65mL Syringe, 1-115mL Syringe, 1-96" Y-Line, and 2 Spikes)
Catalog Number
C853-2201
Brand Name
Coeur
Version/Model Number
C853-2201
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
K161471,K161471
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
5e30f73b-a66c-445f-961f-07fc08d01947
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 11, 2019
Package DI Number
M297722016
Quantity per Package
50
Contains DI Package
M297722010
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 |