Catalog Number

-

Brand Name

Apex

Version/Model Number

71016

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

509e74bd-baa0-4ec0-9b4d-e978678fe0dd

Public Version Date

August 21, 2019

Public Version Number

6

DI Record Publish Date

October 06, 2016

Package DI Number

30076855710167

Quantity per Package

144

Contains DI Package

00076855710166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA