Catalog Number

DT8005A

Brand Name

Centurion

Version/Model Number

DT8005A

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

LRO

Product Code Name

General surgery tray

Public Device Record Key

35ce68cb-e41d-49c3-8ba8-8b803487f190

Public Version Date

May 26, 2020

Public Version Number

1

DI Record Publish Date

May 18, 2020

Package DI Number

10653160188070

Quantity per Package

20

Contains DI Package

00653160188073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE