Catalog Number

EM200

Brand Name

AEM EndoShield® 2 Burn Protection System

Version/Model Number

EM200

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140006,K140006

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

d2c6b647-28a9-4a99-bfe6-04973ad45438

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

20815288013314

Quantity per Package

5

Contains DI Package

10815288013317

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-