Catalog Number

SUT21705

Brand Name

Centurion

Version/Model Number

SUT21705

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

LRP

Product Code Name

TRAY, SURGICAL

Public Device Record Key

68d9b456-235a-47e0-8795-491908a13aa1

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Package DI Number

00653160353839

Quantity per Package

30

Contains DI Package

10653160353836

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE