Catalog Number

OR1821A

Brand Name

Centurion

Version/Model Number

OR1821A

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

MLS

Product Code Name

Labor and Delivery Kit

Public Device Record Key

81b4c217-7d79-4a62-8968-dc3373885b21

Public Version Date

January 03, 2020

Public Version Number

1

DI Record Publish Date

December 26, 2019

Package DI Number

00653160335477

Quantity per Package

6

Contains DI Package

10653160335474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE