Catalog Number

-

Brand Name

Handy Solutions

Version/Model Number

29933

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K991206,K991206

Product Code

LRX

Product Code Name

Case, Contact Lens

Public Device Record Key

2c32a00b-b3dc-4b19-bbc7-a7669feccc22

Public Version Date

March 27, 2020

Public Version Number

4

DI Record Publish Date

December 13, 2016

Package DI Number

10024291299339

Quantity per Package

6

Contains DI Package

00024291299332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON