Catalog Number

-

Brand Name

Flagship

Version/Model Number

1603-000-011

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

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

cffda9a0-94e8-4bb1-8f92-b8b8b7cc90cb

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

April 27, 2021

Package DI Number

10816349012348

Quantity per Package

5

Contains DI Package

00816349012341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-