Catalog Number

VS100ST

Brand Name

Centurion

Version/Model Number

VS100ST

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

HDF

Product Code Name

SPECULUM, VAGINAL, METAL

Public Device Record Key

4e9f7523-e656-4f9a-b7d8-113897a279b7

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 02, 2022

Package DI Number

50653160043650

Quantity per Package

30

Contains DI Package

00653160043655

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE