Catalog Number

7-45332

Brand Name

ViaLume

Version/Model Number

7-45332

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 02, 2020

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"

-

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

43ddd60a-8a4b-479b-902e-d19b42e0a5eb

Public Version Date

March 03, 2020

Public Version Number

3

DI Record Publish Date

April 05, 2017

Package DI Number

20816908010669

Quantity per Package

4

Contains DI Package

10816908010662

Package Discontinue Date

March 02, 2020

Package Status

Not in Commercial Distribution

Package Type

Case