Catalog Number

-

Brand Name

Regard™

Version/Model Number

EY00266G

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2020

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

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

134c0be0-48b6-4928-a96b-15509dfda07c

Public Version Date

August 19, 2020

Public Version Number

3

DI Record Publish Date

November 14, 2019

Package DI Number

20194717100277

Quantity per Package

6

Contains DI Package

10194717100270

Package Discontinue Date

August 19, 2020

Package Status

Not in Commercial Distribution

Package Type

-