Alpha-Stim M - Alpha-Stim M kit - China - Electromedical Products International, Inc.

Duns Number:610954729

Device Description: Alpha-Stim M kit - China

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More Product Details

Catalog Number

-

Brand Name

Alpha-Stim M

Version/Model Number

M

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

001a6550-8ab5-44af-91df-0da85c677a57

Public Version Date

May 23, 2019

Public Version Number

3

DI Record Publish Date

August 25, 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