Catalog Number

1000-086-01

Brand Name

Fluorotron Master

Version/Model Number

FM-Win

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 24, 2017

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

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Public Device Record Key

d7ef6038-2edc-4176-a5bf-3b0e6ea4d2ce

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

December 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-