Catalog Number

-

Brand Name

Centurion

Version/Model Number

DT18770

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

760149c5-ff80-4e6e-9d98-75e32ba47457

Public Version Date

September 10, 2019

Public Version Number

4

DI Record Publish Date

September 08, 2016

Package DI Number

00653160274561

Quantity per Package

16

Contains DI Package

10653160274568

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE