Catalog Number

SUT12850

Brand Name

Centurion

Version/Model Number

SUT12850

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

af339b80-0554-480d-b6da-add75b45c5be

Public Version Date

September 02, 2019

Public Version Number

1

DI Record Publish Date

August 23, 2019

Package DI Number

50653160048068

Quantity per Package

20

Contains DI Package

00653160133844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE