Catalog Number

-

Brand Name

Centurion

Version/Model Number

CAK70

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)

Yes

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

-

Product Code

LRO

Product Code Name

General surgery tray

Public Device Record Key

480db302-a95b-4d07-a6f5-4f858e19fbf5

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

50653160027513

Quantity per Package

24

Contains DI Package

00653160027518

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE