Catalog Number

Not Applicable

Brand Name

EMP Burn Sheet

Version/Model Number

EMP-7010

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

FPY

Product Code Name

Sheet, Burn

Public Device Record Key

7fb2ba01-2440-43ad-8a00-ea6999b70bd0

Public Version Date

January 04, 2022

Public Version Number

1

DI Record Publish Date

December 27, 2021

Package DI Number

00840155411876

Quantity per Package

50

Contains DI Package

00840155411852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case