Catalog Number

-

Brand Name

Centurion

Version/Model Number

DT10430

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

MCY

Product Code Name

Wound dressing kit

Public Device Record Key

5046b5e7-bc6a-4cc3-85ab-17c2ea7b12bc

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

September 07, 2016

Package DI Number

10653160176428

Quantity per Package

20

Contains DI Package

00653160176421

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE