Catalog Number

10825428

Brand Name

Miracle-Ear

Version/Model Number

HA ME 2175 S DGT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2020

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)

Yes

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

3096ef15-f661-487c-ace1-1ab7838c1eb8

Public Version Date

December 01, 2020

Public Version Number

4

DI Record Publish Date

May 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-