Catalog Number

4188T

Brand Name

UP & UP

Version/Model Number

245090197

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2021

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

K991206

Product Code

LRX

Product Code Name

Case, Contact Lens

Public Device Record Key

14cdba29-789e-48a8-82e5-7475e4f4b97e

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

January 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-