Catalog Number

6660

Brand Name

Dukal

Version/Model Number

6660

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)

-

Over the Counter (OTC)

Yes

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

aba1a8aa-a934-4264-9497-3aaf235582d6

Public Version Date

May 23, 2022

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

20665973015631

Quantity per Package

10

Contains DI Package

00665973015637

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case