Catalog Number

-

Brand Name

Fiberoptics Technology Inc

Version/Model Number

LO-50

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

FCW

Product Code Name

Light Source, Fiberoptic, Routine

Public Device Record Key

e17e1528-0035-4e50-91cc-521e9161219e

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

April 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-