Catalog Number

-

Brand Name

Sunoptic Technologies

Version/Model Number

Rover Lightsource series

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FCW

Product Code Name

Light Source, Fiberoptic, Routine

Public Device Record Key

926ee2e9-4531-4b68-ac27-a243cba1427d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-