Catalog Number

ASK-04020-UMMC

Brand Name

ARROW

Version/Model Number

IPN056311

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

6f3c8e7d-7d99-47ea-a1db-46ef5b5ff691

Public Version Date

September 27, 2021

Public Version Number

6

DI Record Publish Date

January 22, 2020

Package DI Number

20801902161394

Quantity per Package

5

Contains DI Package

10801902161397

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case