Catalog Number

180418260

Brand Name

POINTER™ Nitinol Guidewire

Version/Model Number

180418260

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K031442,K031442

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

954ed4d8-ebfb-4dd5-8eae-4c1f2cf6ce28

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

20886333000740

Quantity per Package

5

Contains DI Package

00886333000746

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box