Catalog Number

ASK-21242-GMC1

Brand Name

ARROW

Version/Model Number

IPN034713

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

K011761,K011761

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

44cc2648-839c-4bb6-b45b-513287f51714

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

30801902093371

Quantity per Package

3

Contains DI Package

00801902093370

Package Discontinue Date

September 06, 2018

Package Status

Not in Commercial Distribution

Package Type

Case