Catalog Number

MNS6745

Brand Name

Centurion

Version/Model Number

MNS6745

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

387e158e-ea9e-4da0-b3e3-6ca70ef0e7c6

Public Version Date

September 02, 2019

Public Version Number

1

DI Record Publish Date

August 23, 2019

Package DI Number

10653160224983

Quantity per Package

5

Contains DI Package

00653160224986

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE