Catalog Number

ASK-04020-MHS

Brand Name

ARROW

Version/Model Number

IPN036829

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

24006172-aec1-48dd-a1a8-dfd361707c81

Public Version Date

November 15, 2021

Public Version Number

6

DI Record Publish Date

October 05, 2018

Package DI Number

30801902117718

Quantity per Package

10

Contains DI Package

20801902117711

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case