Catalog Number

ZZAEV906

Brand Name

BodyMed

Version/Model Number

ZZAEV906

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

1ec57703-6dcd-4743-95ec-653b3b9b635a

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

September 05, 2016

Package DI Number

20815802014537

Quantity per Package

20

Contains DI Package

10815802014530

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master carton