Catalog Number

-

Brand Name

Good Sense

Version/Model Number

KC00020

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

-

Product Code

LPN

Product Code Name

Accessories, Soft Lens Products

Public Device Record Key

9b60f03a-4622-497f-a98c-e83eddec22c4

Public Version Date

March 17, 2020

Public Version Number

1

DI Record Publish Date

March 09, 2020

Package DI Number

10180410000207

Quantity per Package

24

Contains DI Package

00180410000200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper