Catalog Number

ASK-04020-UPM1

Brand Name

ARROW

Version/Model Number

IPN055810

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

1838f531-af2e-45ea-9b17-ca68380a86dc

Public Version Date

November 13, 2020

Public Version Number

3

DI Record Publish Date

September 12, 2019

Package DI Number

20801902159490

Quantity per Package

5

Contains DI Package

10801902159493

Package Discontinue Date

September 21, 2020

Package Status

Not in Commercial Distribution

Package Type

Case