Catalog Number

518-035

Brand Name

Quick-Cross™

Version/Model Number

518-035-B

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"

-

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

K033678,K033678

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Public Device Record Key

5e593738-9687-4cb1-a305-4aaf4b4ea403

Public Version Date

March 02, 2022

Public Version Number

1

DI Record Publish Date

February 22, 2022

Package DI Number

20813132029351

Quantity per Package

5

Contains DI Package

00813132029357

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box