Catalog Number

-

Brand Name

medisana

Version/Model Number

MC 32L

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)

-

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

4902863d-a1e5-45f5-8d63-a79c36930c12

Public Version Date

October 21, 2021

Public Version Number

1

DI Record Publish Date

October 13, 2021

Package DI Number

10192918000719

Quantity per Package

3

Contains DI Package

00192918000712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-