Catalog Number

Art.-No. 590.70

Brand Name

Beurer

Version/Model Number

CM100

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

ISA

Product Code Name

Massager, Therapeutic, Electric

Public Device Record Key

8aba1e9a-1157-4f8b-9874-0b28d5ce49f9

Public Version Date

August 20, 2020

Public Version Number

3

DI Record Publish Date

January 07, 2019

Package DI Number

10853879007994

Quantity per Package

2

Contains DI Package

00853879007997

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack