Catalog Number

NA

Brand Name

Whisper Hearing System

Version/Model Number

W1

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

OSM

Product Code Name

Hearing Aid, Air Conduction With Wireless Technology

Public Device Record Key

5bde2473-dc21-4bf1-98df-3d0bc08d05ec

Public Version Date

November 03, 2020

Public Version Number

1

DI Record Publish Date

October 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-