Catalog Number

OS-CFR-L-2

Brand Name

Stainless Steel Cardiac Finger Heart Retractor - Large

Version/Model Number

OS-CFR-L-2

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Public Device Record Key

5b496f04-7299-47ea-9cf0-75ad9c8cf7f8

Public Version Date

August 17, 2021

Public Version Number

4

DI Record Publish Date

November 15, 2016

Package DI Number

B354OSCFRLG210

Quantity per Package

10

Contains DI Package

B354OSCFRLG20

Package Discontinue Date

November 15, 2019

Package Status

Not in Commercial Distribution

Package Type

-