Catalog Number

C405-1501

Brand Name

Coeur

Version/Model Number

C405-1501

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

K942381,K942381,K942381

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

9e64e577-8837-4c35-8aeb-1ae736eaeede

Public Version Date

February 04, 2019

Public Version Number

3

DI Record Publish Date

July 14, 2016

Package DI Number

M297115016

Quantity per Package

2

Contains DI Package

M297115015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper