Catalog Number

HST-085-10/B

Brand Name

HeartSpan®

Version/Model Number

00884450489727

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

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

d3b2720f-1b62-4274-964e-2eb7cbd4f323

Public Version Date

November 08, 2021

Public Version Number

3

DI Record Publish Date

August 10, 2020

Package DI Number

10884450489724

Quantity per Package

5

Contains DI Package

00884450489727

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-