Catalog Number

HERO1006/B

Brand Name

HeRO®

Version/Model Number

00884450320549

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

-

Product Code

DSY

Product Code Name

PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Public Device Record Key

3b668f6b-0a6f-4a88-9a8d-adaf37b08fb7

Public Version Date

October 11, 2021

Public Version Number

3

DI Record Publish Date

January 10, 2019

Package DI Number

10884450320546

Quantity per Package

1

Contains DI Package

00884450320549

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-