Catalog Number

9-05-00338-3

Brand Name

ZPower Rechargeable System for Hearing Aids

Version/Model Number

Z601-312

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

ESD

Product Code Name

Hearing Aid, Air Conduction

Public Device Record Key

52239838-9cdb-4122-bdbc-322d7eab1342

Public Version Date

February 06, 2020

Public Version Number

3

DI Record Publish Date

May 14, 2018

Package DI Number

10811204030192

Quantity per Package

1

Contains DI Package

00811204030195

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-