Catalog Number

32-1874

Brand Name

DeRoyal

Version/Model Number

32-1874

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KEW

Product Code Name

SLIDES, MICROSCOPE

Public Device Record Key

97d0755a-2dd8-46c5-888d-f5a3e28aeae6

Public Version Date

August 13, 2021

Public Version Number

1

DI Record Publish Date

August 05, 2021

Package DI Number

30749756741607

Quantity per Package

2

Contains DI Package

00749756741606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box