Catalog Number

-

Brand Name

N/A

Version/Model Number

DM1000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 05, 2017

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

642d7983-ca61-4fbe-95f3-9d5f9119f361

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 12, 2016

Package DI Number

80092237612848

Quantity per Package

100

Contains DI Package

00092237612842

Package Discontinue Date

May 05, 2017

Package Status

Not in Commercial Distribution

Package Type

CA