Catalog Number

-

Brand Name

Centurion

Version/Model Number

PE752ST

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

HIB

Product Code Name

Speculum, vaginal, nonmetal

Public Device Record Key

7cc899bc-cf4d-4a37-a8aa-7bf8053d8011

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 03, 2017

Package DI Number

50653160049171

Quantity per Package

25

Contains DI Package

00653160049176

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE