Catalog Number

-

Brand Name

Apex

Version/Model Number

71020

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

736b7c64-97b4-43b7-99e0-ac4d828afa3d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 06, 2016

Package DI Number

30076855710204

Quantity per Package

144

Contains DI Package

00076855710203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA