Catalog Number

-

Brand Name

Centurion

Version/Model Number

3K16C1820

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OES

Product Code Name

Cardiac catheterization kit

Public Device Record Key

ae031b7e-c9eb-482d-b49b-d8e9e3d970bb

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

00653160247008

Quantity per Package

5

Contains DI Package

10653160247005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE