Catalog Number

4186T

Brand Name

Up & Up

Version/Model Number

245090202

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

c6276332-014b-4169-86a2-a63099734118

Public Version Date

September 13, 2021

Public Version Number

3

DI Record Publish Date

April 07, 2020

Package DI Number

10078041200342

Quantity per Package

6

Contains DI Package

00078041200345

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner pack