Catalog Number

-

Brand Name

Up & Up

Version/Model Number

245090197

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

K991206,K991206,K991206

Product Code

LRX

Product Code Name

Case, Contact Lens

Public Device Record Key

3095ef9f-4051-45ed-8d2e-3f2490e473ee

Public Version Date

September 13, 2021

Public Version Number

3

DI Record Publish Date

April 07, 2020

Package DI Number

10078041200335

Quantity per Package

6

Contains DI Package

00078041200338

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner pack