Catalog Number

C405-1569

Brand Name

Coeur

Version/Model Number

C405-1569

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

6baed99c-1cca-4a1d-a6d9-05894670f918

Public Version Date

February 04, 2019

Public Version Number

3

DI Record Publish Date

July 14, 2016

Package DI Number

M297115696

Quantity per Package

2

Contains DI Package

M297115695

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper