Catalog Number

-

Brand Name

Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal

Version/Model Number

FM-PM-3

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

K905067,K905067,K905067

Product Code

DSY

Product Code Name

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Public Device Record Key

12e85959-f03c-4324-8a49-878643f45294

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

February 01, 2017

Package DI Number

B040FMPM32

Quantity per Package

3

Contains DI Package

B040FMPM31

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-