Catalog Number

GH-04120

Brand Name

ARROW

Version/Model Number

IPN033172

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

K810675,K810675

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

e7630e53-4aea-4c1d-963f-fd6510e358bd

Public Version Date

July 28, 2022

Public Version Number

9

DI Record Publish Date

September 16, 2016

Package DI Number

30801902100611

Quantity per Package

25

Contains DI Package

00801902100610

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case