Catalog Number

-

Brand Name

ProOcular Daily Disposable Contact Lens

Version/Model Number

-9.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2019

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

Yes

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

MVN

Product Code Name

Lens, Contact, (Disposable)

Public Device Record Key

fa541d0e-ae8d-4345-9e60-202bd9523900

Public Version Date

September 20, 2021

Public Version Number

3

DI Record Publish Date

October 28, 2016

Package DI Number

40816816880648

Quantity per Package

6

Contains DI Package

30816816880641

Package Discontinue Date

December 01, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton