ZPower Rechargeable System for Hearing Aids - Battery Door Module for ZPower Rechargeable - ZPOWER, LLC

Duns Number:061455809

Device Description: Battery Door Module for ZPower Rechargeable System for Hearing Aids

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


More Product Details

Catalog Number

9-05-00245-05

Brand Name

ZPower Rechargeable System for Hearing Aids

Version/Model Number

Z701-312

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

ESD

Product Code Name

Hearing Aid, Air Conduction

Device Record Status

Public Device Record Key

b42997d8-ca19-4fc6-9791-303a5b262be4

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

May 01, 2019

Additional Identifiers

Package DI Number

10811204030567

Quantity per Package

1

Contains DI Package

00811204030560

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Alt 9-06-00109-05S

"ZPOWER, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 59