Catalog Number

-

Brand Name

Centurion

Version/Model Number

DT14680

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

MCY

Product Code Name

Wound dressing kit

Public Device Record Key

b146f58c-fe15-405d-9770-e588e8d7a02a

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

September 08, 2016

Package DI Number

00653160239980

Quantity per Package

50

Contains DI Package

10653160239987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE