Catalog Number

-

Brand Name

N/A

Version/Model Number

DE5030

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)

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

15c53c69-56c6-4026-9c13-a92147575d86

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 12, 2016

Package DI Number

80092237616648

Quantity per Package

32

Contains DI Package

00092237616642

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA