Catalog Number

497905A

Brand Name

Catheter Introducer Tray

Version/Model Number

497905A

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

K780126,K780126

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Public Device Record Key

571de997-702f-4689-a919-de43cf50d3e9

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

20886333215496

Quantity per Package

10

Contains DI Package

00886333215492

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box