Catalog Number

MR500ST

Brand Name

Centurion

Version/Model Number

MR500ST

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

GAD

Product Code Name

RETRACTOR

Public Device Record Key

9cd08b11-54a7-4414-91cf-da2727a14886

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 02, 2022

Package DI Number

70653160037356

Quantity per Package

25

Contains DI Package

00653160037357

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE