Catalog Number

-

Brand Name

Centurion

Version/Model Number

CS200

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

HFW

Product Code Name

Clamp, umbilical

Public Device Record Key

cb8007ce-3b30-4f96-9691-bdca0963d530

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 03, 2017

Package DI Number

50653160021382

Quantity per Package

200

Contains DI Package

00653160021387

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE