Catalog Number

-

Brand Name

Anastomark Coronary Artery Bypass Graft Markers, Stainless Steel, Distal

Version/Model Number

AMGM-SD

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

-

Product Code

DSY

Product Code Name

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Public Device Record Key

35774f7f-1278-44e1-8550-d57049671c2c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 01, 2017

Package DI Number

B040AMGMSD2

Quantity per Package

25

Contains DI Package

B040AMGMSD1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-