Catalog Number

67850

Brand Name

Centurion

Version/Model Number

67850

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

850cc94c-3108-4a23-ac3e-b0f75aa9256d

Public Version Date

December 07, 2021

Public Version Number

1

DI Record Publish Date

November 29, 2021

Package DI Number

00653160349009

Quantity per Package

20

Contains DI Package

10653160349006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE