Catalog Number

-

Brand Name

Sof-Flo Atraumatic Coronary Artery Shunt

Version/Model Number

SHT-1218S-C01

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K972665

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Public Device Record Key

e3a8e0df-e551-46b3-830d-3ef8678dc8e4

Public Version Date

May 02, 2019

Public Version Number

1

DI Record Publish Date

April 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-