Alpha-Stim 100 - Alpha-Stim 100 kit - Electromedical Products International, Inc.

Duns Number:610954729

Device Description: Alpha-Stim 100 kit

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Alpha-Stim 100

Version/Model Number

100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

a6aef59c-a777-4946-934c-4d094db53072

Public Version Date

May 23, 2019

Public Version Number

3

DI Record Publish Date

October 28, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELECTROMEDICAL PRODUCTS INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10
3 A medical device with high risk that requires premarket approval 7