Catalog Number

ES5107

Brand Name

AEM® Burn Protection System Cable

Version/Model Number

ES5107

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

23e67ac2-15a5-47db-8f9f-683b59a3c05b

Public Version Date

May 08, 2018

Public Version Number

3

DI Record Publish Date

January 31, 2017

Package DI Number

20815288013697

Quantity per Package

25

Contains DI Package

10815288013690

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-