Catalog Number

SK385

Brand Name

Centurion

Version/Model Number

SK385

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OJU

Product Code Name

Skin prep tray

Public Device Record Key

3c779853-f366-4f44-b19a-971923e05f7b

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 02, 2022

Package DI Number

10653160232926

Quantity per Package

20

Contains DI Package

00653160232929

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE