Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

89-9241

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

4f059e91-0f93-48ab-a97f-0811a0ed8837

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

October 04, 2017

Package DI Number

50749756939534

Quantity per Package

18

Contains DI Package

00749756939539

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case