Catalog Number

080300

Brand Name

AORTIC ROOT RETRACTOR

Version/Model Number

080300

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

DWS

Product Code Name

INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Public Device Record Key

467d1226-607c-44f5-952c-b043afcf0d95

Public Version Date

March 30, 2020

Public Version Number

2

DI Record Publish Date

March 13, 2020

Package DI Number

10850200006558

Quantity per Package

6

Contains DI Package

00850200006551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box