Catalog Number

BTK-14-2H21150-A1

Brand Name

ARROW

Version/Model Number

IPN000413

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

K142300,K142300,K142300

Product Code

LIT

Product Code Name

Catheter, angioplasty, peripheral, transluminal

Public Device Record Key

413783cb-b7c9-4e95-8da5-1891cc415e34

Public Version Date

December 19, 2019

Public Version Number

5

DI Record Publish Date

April 20, 2017

Package DI Number

40801902084093

Quantity per Package

10

Contains DI Package

30801902084096

Package Discontinue Date

December 18, 2019

Package Status

Not in Commercial Distribution

Package Type

Case