Catalog Number

-

Brand Name

Beurer

Version/Model Number

IL50

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

d5acd7f8-3aea-4fa9-b6e0-97ec615e1a00

Public Version Date

February 25, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10852547004105

Quantity per Package

2

Contains DI Package

00852547004108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack