Catalog Number

-

Brand Name

Fischer

Version/Model Number

MD-2 Galvanic Unit

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EGJ

Product Code Name

Device, Iontophoresis, Other Uses

Public Device Record Key

7e4f4722-b78e-4b39-a4a6-3521c5d345c3

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 16, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-