Catalog Number

-

Brand Name

ACIST CVi® Angiographic Injection System Injector Head

Version/Model Number

014657

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 20, 2019

Issuing Agency

In GS1

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

-

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

-

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

99a70e35-3ed2-4b66-abb9-66f5f77ad48c

Public Version Date

April 15, 2019

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

30841716100605

Quantity per Package

1

Contains DI Package

10841716100601

Package Discontinue Date

February 20, 2019

Package Status

Not in Commercial Distribution

Package Type

Shelf box