Catalog Number

-

Brand Name

Medisana

Version/Model Number

E-1520-CB9

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

a0a894aa-27e1-49a8-afd1-da18a7579d18

Public Version Date

September 21, 2021

Public Version Number

1

DI Record Publish Date

September 13, 2021

Package DI Number

16973425450037

Quantity per Package

2

Contains DI Package

06973425450030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-