Catalog Number

PG6F45S

Brand Name

Prelude Roadster™

Version/Model Number

00884450531969

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

9d3cb5bd-3d3f-4688-a702-d6c822e691ca

Public Version Date

July 28, 2022

Public Version Number

1

DI Record Publish Date

July 20, 2022

Package DI Number

10884450531966

Quantity per Package

5

Contains DI Package

00884450531969

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-