Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

AM3

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

-

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

FTA

Product Code Name

Light, surgical, accessories

Public Device Record Key

c8336911-6dea-4546-97d6-bc3cd168a41e

Public Version Date

August 27, 2018

Public Version Number

1

DI Record Publish Date

July 25, 2018

Package DI Number

50749756954568

Quantity per Package

1

Contains DI Package

00749756954563

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case