Catalog Number

-

Brand Name

OptiLux LED Illuminator

Version/Model Number

OptiLux

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2026

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K163185

Product Code

HBI

Product Code Name

Illuminator, Fiberoptic, Surgical Field

Public Device Record Key

8cc8ad0c-f125-4665-93b1-376b8faf43ed

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

December 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-