Catalog Number

C853-0210

Brand Name

Coeur

Version/Model Number

C853-0210

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

9b79d3f5-46ba-46bf-b7f3-ef26a06c0551

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 14, 2016

Package DI Number

M297702106

Quantity per Package

50

Contains DI Package

M297702100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper