Catalog Number

-

Brand Name

Color Case

Version/Model Number

CC17

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

6854fc71-e0f9-4910-aa61-9c5f462e4ee0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 22, 2017

Package DI Number

10897522001076

Quantity per Package

60

Contains DI Package

00897522001079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-