Catalog Number

C853-3102

Brand Name

Coeur

Version/Model Number

C853-3102

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

K170431,K170431

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

0ed7bf64-99a6-4b49-9b7d-42101a5799d6

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 11, 2019

Package DI Number

M297731026

Quantity per Package

50

Contains DI Package

M297731020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper