Catalog Number

-

Brand Name

SynRG Light Pad

Version/Model Number

55105

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)

Yes

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

4a5df333-119f-4859-a95b-141774bf8017

Public Version Date

August 15, 2022

Public Version Number

4

DI Record Publish Date

September 13, 2019

Package DI Number

10860000214022

Quantity per Package

10

Contains DI Package

00860000214025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-