Catalog Number

HD-397-0001EU

Brand Name

DeRoyal

Version/Model Number

HD-397-0001EU

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Public Device Record Key

0c9f728f-c82c-47c0-928a-ea64b1d02854

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

June 23, 2021

Package DI Number

50749756837670

Quantity per Package

750

Contains DI Package

00749756837675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case