Catalog Number

-

Brand Name

Regard™

Version/Model Number

EY0812

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OJK

Product Code Name

Eye Tray

Public Device Record Key

f66c3458-cc27-4723-8278-ff022d9f3fd3

Public Version Date

July 31, 2020

Public Version Number

4

DI Record Publish Date

December 05, 2016

Package DI Number

20326053111970

Quantity per Package

3

Contains DI Package

10326053111973

Package Discontinue Date

July 30, 2020

Package Status

Not in Commercial Distribution

Package Type

-