Catalog Number

-

Brand Name

EZcase

Version/Model Number

EZ11

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

Yes

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

K130753,K130753

Product Code

LRX

Product Code Name

Case, Contact Lens

Public Device Record Key

9cd8156a-c747-4104-a4c5-6886485fd65e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 06, 2016

Package DI Number

10897522001595

Quantity per Package

144

Contains DI Package

00897522001598

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-