Catalog Number

71-18836

Brand Name

Lumindex 3 LED Transilluminator Standard 3mm Light Guide

Version/Model Number

7118836

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HJN

Product Code Name

Transilluminator, Battery-Powered

Public Device Record Key

85da3f9c-e8fe-4682-8a76-44ef02713d56

Public Version Date

August 20, 2018

Public Version Number

1

DI Record Publish Date

July 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-