Catalog Number

AK-04660-S

Brand Name

ARROW

Version/Model Number

IPN032627

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

K810962,K810962

Product Code

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

8dc69e70-0286-4dca-a136-857bb03c5207

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

October 25, 2018

Package DI Number

10801902067354

Quantity per Package

5

Contains DI Package

20801902067351

Package Discontinue Date

October 07, 2019

Package Status

Not in Commercial Distribution

Package Type

Case