Catalog Number

1000-086-01

Brand Name

Fluorotron Master

Version/Model Number

FM-Win

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

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Public Device Record Key

6a8a2974-22bf-4015-92c8-885f84296b01

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

January 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-