Catalog Number

MNS12955A

Brand Name

Centurion

Version/Model Number

MNS12955A

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

LRP

Product Code Name

TRAY, SURGICAL

Public Device Record Key

ea35cd3d-24da-4868-bdb5-c4dfecd2b8d3

Public Version Date

September 12, 2022

Public Version Number

1

DI Record Publish Date

September 03, 2022

Package DI Number

00653160355000

Quantity per Package

6

Contains DI Package

10653160355007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE