Catalog Number

HERO1000/B

Brand Name

HeRO®

Version/Model Number

00884450320563

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

7a902316-4a0c-452f-80cf-571268547cee

Public Version Date

October 11, 2021

Public Version Number

5

DI Record Publish Date

February 14, 2018

Package DI Number

10884450320560

Quantity per Package

1

Contains DI Package

00884450320563

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-