Catalog Number

MNS10995

Brand Name

Centurion

Version/Model Number

MNS10995

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

48b33784-73bf-4d86-98c0-18d8ba464a2c

Public Version Date

January 06, 2020

Public Version Number

1

DI Record Publish Date

December 29, 2019

Package DI Number

00653160336917

Quantity per Package

5

Contains DI Package

10653160336914

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE