Catalog Number

-

Brand Name

Healite II

Version/Model Number

Healite Body Assy

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)

Yes

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

9d09dc36-44c6-43a9-89b9-ac5b4571166c

Public Version Date

August 24, 2021

Public Version Number

5

DI Record Publish Date

September 09, 2016

Package DI Number

8809447651705

Quantity per Package

1

Contains DI Package

08809447651699

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton case