Catalog Number

ASK-04001-VCUH1

Brand Name

ARROW

Version/Model Number

IPN036330

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

K003006,K003006

Product Code

LIT

Product Code Name

Catheter, angioplasty, peripheral, transluminal

Public Device Record Key

a40359ed-11cc-44e4-9aad-326270b50ab8

Public Version Date

October 06, 2020

Public Version Number

6

DI Record Publish Date

September 30, 2016

Package DI Number

20801902112990

Quantity per Package

3

Contains DI Package

10801902112993

Package Discontinue Date

August 01, 2018

Package Status

Not in Commercial Distribution

Package Type

Case