Catalog Number

AA-20624-1

Brand Name

ARROW

Version/Model Number

IPN000026

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

K112554,K112554

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

d6936387-9c8c-4a60-9b77-02d849324b0e

Public Version Date

March 04, 2020

Public Version Number

6

DI Record Publish Date

February 05, 2016

Package DI Number

30801902077357

Quantity per Package

5

Contains DI Package

00801902077356

Package Discontinue Date

February 27, 2020

Package Status

Not in Commercial Distribution

Package Type

Box