Catalog Number

05-09WS

Brand Name

Isolux llc

Version/Model Number

FO-2088

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2025

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

-

Product Code

FST

Product Code Name

Light, Surgical, Fiberoptic

Public Device Record Key

c2187ba8-eb97-46f0-a38e-8ec812b57aee

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-