Catalog Number

ASK-04100-CC

Brand Name

ARROW

Version/Model Number

IPN036062

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K810675,K810675

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

26ac2d36-5133-4ed2-9df3-16bd68f1582e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

30801902111327

Quantity per Package

5

Contains DI Package

00801902111326

Package Discontinue Date

August 08, 2017

Package Status

Not in Commercial Distribution

Package Type

Case