Catalog Number

SUT11805

Brand Name

Centurion

Version/Model Number

SUT11805

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

633870f4-ca87-4fc9-bc34-a8ac87bf1baa

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

January 02, 2022

Package DI Number

20653160112652

Quantity per Package

12

Contains DI Package

00653160112658

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE