Catalog Number

-

Brand Name

Centurion

Version/Model Number

SA4816HKI

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

596f53e8-b854-45ad-8035-d058bcaeaa7c

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 14, 2016

Package DI Number

00653160247121

Quantity per Package

5

Contains DI Package

10653160247128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE