Catalog Number

-

Brand Name

Optic Shop

Version/Model Number

125

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K875197,K875197

Product Code

LRX

Product Code Name

Case, Contact Lens

Public Device Record Key

4feb9397-f7d7-4570-93bb-e1278b6bb85e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

20075063012509

Quantity per Package

144

Contains DI Package

00075063012505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case