Catalog Number

AC-3043

Brand Name

Aortic Cutter 4.3MM

Version/Model Number

AC-3043

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

-

Product Code

FZT

Product Code Name

Cutter, Surgical

Public Device Record Key

593d03b4-3675-4b9a-9033-198a5d84b5a6

Public Version Date

May 30, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

00607567700271

Quantity per Package

5

Contains DI Package

00607567700277

Package Discontinue Date

May 29, 2018

Package Status

Not in Commercial Distribution

Package Type

5 pack box