Catalog Number

-

Brand Name

Centurion

Version/Model Number

CLCK001-5

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

-

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

-

FDA Premarket Submission

-

Product Code

DRS

Product Code Name

TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Public Device Record Key

8a6848b8-3a90-451e-ba4a-59b1b82d6469

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

September 10, 2016

Package DI Number

00653160288292

Quantity per Package

5

Contains DI Package

20653160288296

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX