Catalog Number

SW35DE80SST

Brand Name

Prelude® Guide Wire

Version/Model Number

10884450032586

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

K002289,K002289,K002289

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

16d9968a-3790-4eaf-b401-2932607ff866

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

20884450032583

Quantity per Package

10

Contains DI Package

10884450032586

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-