Catalog Number

CMP-SSL-8500

Brand Name

Cardio EP LED Headlight

Version/Model Number

1

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HPP

Product Code Name

Headlamp, Operating, Battery-Operated

Public Device Record Key

a7afc88e-a95b-412c-87f2-6bbb1f4e2ced

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

July 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-