Catalog Number

FC0311-45

Brand Name

AEM® Disposable Electrode, L-Diamond

Version/Model Number

FC0311-45

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

df00068d-0719-4476-9e2e-c10d203ea1eb

Public Version Date

October 29, 2020

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

20815288012508

Quantity per Package

10

Contains DI Package

10815288012501

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-