Catalog Number

-

Brand Name

Ember™

Version/Model Number

EMOCS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Public Device Record Key

a83b63f3-b473-491b-a240-14af81cf40f0

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

July 31, 2019

Package DI Number

B347EMOCS1

Quantity per Package

24

Contains DI Package

B347EMOCS0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-