Catalog Number

FA-04020

Brand Name

ARROW

Version/Model Number

IPN033170

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

-

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

-

FDA Premarket Submission

K810675,K810675,K810675

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

08cfaeee-fd48-4c21-9661-85e0f609f301

Public Version Date

January 25, 2022

Public Version Number

14

DI Record Publish Date

September 16, 2016

Package DI Number

30801902100604

Quantity per Package

1

Contains DI Package

20801902100607

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case