Alpha-Stim Conducting Solution - Alpha-Stim Conducting Solution 250 ml - Electromedical Products International, Inc.

Duns Number:610954729

Device Description: Alpha-Stim Conducting Solution 250 ml

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


More Product Details

Catalog Number

-

Brand Name

Alpha-Stim Conducting Solution

Version/Model Number

SL250

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

Yes

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

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Device Record Status

Public Device Record Key

54110224-6c79-4b35-bf23-3640db5f1e48

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

November 30, 2021

Additional Identifiers

Package DI Number

00857869005291

Quantity per Package

48

Contains DI Package

00857869005284

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"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