Avazzia - Convenience kit with Avazzia Blue device, - AVAZZIA INC

Duns Number:603638607

Device Description: Convenience kit with Avazzia Blue device, conductive pads, lead wire, and zipper pouch.

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More Product Details

Catalog Number

A4-AB-K

Brand Name

Avazzia

Version/Model Number

A4-AB-K

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 20, 2017

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)

Yes

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

cff843af-1f68-4a90-ae02-a9f1b5c749bb

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVAZZIA INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 57