Catalog Number

-

Brand Name

FLUOREX®500

Version/Model Number

FLX500

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

K991780

Product Code

HQD

Product Code Name

Lens, Contact (Other Material) - Daily

Public Device Record Key

2d367dca-4c0b-4c47-a583-77c15d59d06e

Public Version Date

July 17, 2018

Public Version Number

5

DI Record Publish Date

September 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-