Catalog Number

1215-000-211

Brand Name

Rapidwire Plus

Version/Model Number

RWIRE PLS, LT,NOR,S,HY 195-018

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

8d929ee0-2a3e-4b0a-845c-c606fba013b5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 05, 2017

Package DI Number

10816349011037

Quantity per Package

5

Contains DI Package

00816349011030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton