Catalog Number

-

Brand Name

Centurion

Version/Model Number

VS2000LST

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

0cc097da-420e-4c1b-84e2-91dd706527bb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 14, 2016

Package DI Number

00653160268997

Quantity per Package

25

Contains DI Package

10653160268994

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE