Catalog Number

9-06-00075-4

Brand Name

ZPower Rechargeable System for Sophono

Version/Model Number

SZ401-00

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

ffeca1f1-5788-4205-8380-929dbeed8222

Public Version Date

February 06, 2020

Public Version Number

3

DI Record Publish Date

September 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-