Catalog Number

-

Brand Name

Centurion

Version/Model Number

PE3495

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

Yes

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

91568360-722b-4410-89e8-7336d5a803f9

Public Version Date

January 16, 2019

Public Version Number

2

DI Record Publish Date

March 29, 2018

Package DI Number

00653160315851

Quantity per Package

15

Contains DI Package

10653160315858

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE