Catalog Number

00325

Brand Name

SPECULUX

Version/Model Number

31074

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

8a242065-2279-4c03-a09b-cfd8a701ad59

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 11, 2016

Package DI Number

25060489400134

Quantity per Package

4

Contains DI Package

15060489400137

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton