Catalog Number

BINTSS

Brand Name

BREEZE® INTRODUCER KIT

Version/Model Number

BINTSS

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"

Yes

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

OFL

Product Code Name

Percutaneous sheath introducer kit

Public Device Record Key

d6ac8da8-05be-45ea-b8e0-70a44db89025

Public Version Date

March 07, 2022

Public Version Number

1

DI Record Publish Date

February 26, 2022

Package DI Number

30884908139342

Quantity per Package

5

Contains DI Package

00884908139341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner box