Catalog Number

SUT20780

Brand Name

Centurion

Version/Model Number

SUT20780

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Public Device Record Key

e298a571-ee1d-4f1a-84fb-ff16794b1165

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

January 02, 2022

Package DI Number

00653160318579

Quantity per Package

50

Contains DI Package

10653160318576

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE