Catalog Number

SW21A80PW

Brand Name

Prelude®

Version/Model Number

10884450208257

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

K142051,K142051,K142051

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

701442e3-1457-4acf-9ac2-233800cb59cb

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884450208254

Quantity per Package

14

Contains DI Package

10884450208257

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-