Catalog Number

PW-18080-HN

Brand Name

ARROW

Version/Model Number

IPN035908

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

K070150,K070150,K070150

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

e70e5842-a3f0-4851-a714-7ce40bfcd9de

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

November 19, 2019

Package DI Number

20801902156727

Quantity per Package

1

Contains DI Package

30801902156724

Package Discontinue Date

November 17, 2021

Package Status

Not in Commercial Distribution

Package Type

Case