Duns Number:132515441
Device Description: 130mL Angiographic Syringe includes (1) J-Tube
Catalog Number
C853-0130
Brand Name
Coeur
Version/Model Number
C853-0130
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
K971712,K971712
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
ed9b532d-a649-478c-bf7c-74a9bad8d36a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 14, 2016
Package DI Number
M297701306
Quantity per Package
50
Contains DI Package
M297701300
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 71 |