Catalog Number

-

Brand Name

Centurion

Version/Model Number

WT1200

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

1e7355e9-13f9-4484-b664-69ff80361293

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 03, 2017

Package DI Number

60653160017801

Quantity per Package

16

Contains DI Package

00653160017809

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE