Catalog Number

-

Brand Name

PainBuster

Version/Model Number

Painbuster

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 05, 2025

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

2dbdf43b-bae2-4f16-8f0c-8685a3d5fad0

Public Version Date

April 28, 2020

Public Version Number

1

DI Record Publish Date

April 20, 2020

Package DI Number

10860003478100

Quantity per Package

14

Contains DI Package

00860003478103

Package Discontinue Date

April 05, 2025

Package Status

In Commercial Distribution

Package Type

Carton