Catalog Number

ASK-04020-SHUF

Brand Name

ARROW

Version/Model Number

IPN056190

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

88c1fed7-faa1-4784-ac1d-ce9a290b4deb

Public Version Date

March 26, 2021

Public Version Number

4

DI Record Publish Date

November 20, 2019

Package DI Number

20801902160717

Quantity per Package

5

Contains DI Package

10801902160710

Package Discontinue Date

March 25, 2021

Package Status

Not in Commercial Distribution

Package Type

Case