Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

81-010003

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

KPD

Product Code Name

STRIP, TEMPERATURE, FOREHEAD, LIQUID CRYSTAL

Public Device Record Key

d6ba54fe-cabf-4526-90f1-21f1bf2d6481

Public Version Date

August 11, 2021

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

50749756142040

Quantity per Package

100

Contains DI Package

00749756142045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case