Catalog Number

519-005

Brand Name

Quick-Access™

Version/Model Number

519-005AA

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

K112887,K112887

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

05e2002c-fcb8-49fc-9d6c-2d72c8b20177

Public Version Date

October 10, 2022

Public Version Number

5

DI Record Publish Date

February 06, 2015

Package DI Number

20813132020730

Quantity per Package

5

Contains DI Package

00813132020736

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box