Catalog Number

CS-12402

Brand Name

ARROW

Version/Model Number

IPN033013

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

eb9ead09-5a99-483e-a501-90b0e35a4fa5

Public Version Date

May 05, 2022

Public Version Number

6

DI Record Publish Date

April 04, 2018

Package DI Number

20801902124313

Quantity per Package

5

Contains DI Package

30801902124310

Package Discontinue Date

May 04, 2022

Package Status

Not in Commercial Distribution

Package Type

Case