Catalog Number

-

Brand Name

Omnipad Light Therapy, Dual 5x7 Pads

Version/Model Number

76896

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K060191,K060191

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Public Device Record Key

c8b9e4f9-0ae1-4fe3-ad67-c3a65870bbb3

Public Version Date

March 10, 2020

Public Version Number

5

DI Record Publish Date

August 16, 2016

Package DI Number

10858703006068

Quantity per Package

24

Contains DI Package

00858703006061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case