Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

89-8392

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

LRO

Product Code Name

General surgery tray

Public Device Record Key

512e77e1-8ce3-4d73-a4e0-2f8e4f8150c3

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

50749756832439

Quantity per Package

3

Contains DI Package

00749756832434

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case