Catalog Number

SUT14815

Brand Name

Centurion

Version/Model Number

SUT14815

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

KDD

Product Code Name

Kit, surgical instrument, disposable

Public Device Record Key

daadce5f-bf95-4c28-afb8-2a96a2d8d266

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

January 02, 2022

Package DI Number

10653160188049

Quantity per Package

30

Contains DI Package

00653160188042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE