Catalog Number

-

Brand Name

Centurion

Version/Model Number

HUD112ST

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

KNA

Product Code Name

INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Public Device Record Key

a46f9be1-8287-4ce3-9ed3-6e4c9cf0fa73

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 13, 2016

Package DI Number

50653160068288

Quantity per Package

5

Contains DI Package

00653160068283

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE