Catalog Number

6012

Brand Name

Tech-Med

Version/Model Number

6012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 14, 2020

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

K032720,K032720

Product Code

IPF

Product Code Name

Stimulator, muscle, powered

Public Device Record Key

a5a91270-45a2-4988-aced-b0299e69628b

Public Version Date

May 23, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20665973016775

Quantity per Package

30

Contains DI Package

00665973016771

Package Discontinue Date

October 14, 2020

Package Status

Not in Commercial Distribution

Package Type

Case