Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

89-7876

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

5c079dbf-b1e3-41ad-8580-13b71a308a4b

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

50749756779611

Quantity per Package

20

Contains DI Package

00749756779616

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case