Catalog Number

-

Brand Name

Centurion

Version/Model Number

WT1340A

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

edbe14a5-8b9f-4fc9-9157-5d84741b1dc3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 03, 2017

Package DI Number

20653160200311

Quantity per Package

24

Contains DI Package

00653160200317

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE