Catalog Number

-

Brand Name

OPTI-FREE

Version/Model Number

OPTI-FREE LENS CASE

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LRX

Product Code Name

Case, contact lens

Public Device Record Key

7cddd9d3-48f1-4130-9393-1ddf4b03d71a

Public Version Date

January 24, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20300650180072

Quantity per Package

24

Contains DI Package

00300650180078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case