Catalog Number

C855-5304

Brand Name

Coeur Nemoto

Version/Model Number

C855-5304

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

K051799,K051799

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

7c7b8240-919f-4d7b-bc6d-0ccc6c5a7399

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 15, 2016

Package DI Number

M902553046

Quantity per Package

20

Contains DI Package

M902553040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper