Catalog Number

EWU01

Brand Name

Earlens Wireless Updater

Version/Model Number

EWU01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 10, 2018

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

PLK

Product Code Name

Tympanic Membrane Direct Contact Hearing Aid

Public Device Record Key

4f8e3651-8bd7-46ab-b162-345c4b09b7b8

Public Version Date

April 08, 2022

Public Version Number

7

DI Record Publish Date

October 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-