Catalog Number

C856-0060

Brand Name

Coeur Acist

Version/Model Number

C856-0060

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)

-

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

fd478285-b7b3-4a0c-b439-7b1a785cd5a8

Public Version Date

February 04, 2019

Public Version Number

3

DI Record Publish Date

July 15, 2016

Package DI Number

M297600606

Quantity per Package

100

Contains DI Package

M297600600

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper