Catalog Number

AW-17752

Brand Name

ARROW

Version/Model Number

IPN035374

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

K935170,K935170,K935170

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

c21b1467-5757-4a41-986c-d1e47584f9b3

Public Version Date

December 22, 2021

Public Version Number

7

DI Record Publish Date

September 16, 2016

Package DI Number

30801902003257

Quantity per Package

1

Contains DI Package

20801902003250

Package Discontinue Date

March 12, 2020

Package Status

Not in Commercial Distribution

Package Type

Case