Catalog Number

-

Brand Name

Centurion

Version/Model Number

ST14910A

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

a5eefe8c-3f2a-4aab-aa8b-126a18967255

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

March 03, 2017

Package DI Number

10653160215899

Quantity per Package

12

Contains DI Package

00653160215892

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE