Catalog Number

CV-15553

Brand Name

ARROW

Version/Model Number

IPN036099

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

K862056,K862056

Product Code

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

49ac2cf5-8184-46d3-92af-82e78f4048af

Public Version Date

March 04, 2021

Public Version Number

6

DI Record Publish Date

May 02, 2018

Package DI Number

30801902122606

Quantity per Package

10

Contains DI Package

20801902122609

Package Discontinue Date

February 26, 2021

Package Status

Not in Commercial Distribution

Package Type

Case