Catalog Number

-

Brand Name

Centurion

Version/Model Number

MNS9975

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

6801b977-fef2-411e-b52d-d5d15902d1f2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 11, 2016

Package DI Number

00653160291582

Quantity per Package

12

Contains DI Package

10653160291589

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE