Catalog Number

Art.- No. 619.73

Brand Name

Beurer

Version/Model Number

IL51

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

f2156890-44a3-4585-8377-e6a6dfc410ec

Public Version Date

March 12, 2019

Public Version Number

1

DI Record Publish Date

March 04, 2019

Package DI Number

10850003500048

Quantity per Package

2

Contains DI Package

00850003500041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack