Catalog Number

CR12ST

Brand Name

Centurion

Version/Model Number

CR12ST

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

NAB

Product Code Name

Gauze / sponge,nonresorbable for external use

Public Device Record Key

4c8ed930-adb0-4eb3-93bf-2e24554f1af6

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 01, 2022

Package DI Number

50653160003685

Quantity per Package

12

Contains DI Package

00653160003680

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE