Miracle-Ear - Miracle-Ear HA ME 3300 MINI RIC GR Hearing Aid - SIVANTOS, INC.

Duns Number:157412271

Device Description: Miracle-Ear HA ME 3300 MINI RIC GR Hearing Aid

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

10932425

Brand Name

Miracle-Ear

Version/Model Number

HA ME 3300 MINI RIC GR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2020

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

ESD

Product Code Name

Hearing Aid, Air Conduction

Device Record Status

Public Device Record Key

4d8241ee-0679-4e2a-9167-db1262fb5f0c

Public Version Date

December 01, 2020

Public Version Number

4

DI Record Publish Date

May 06, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIVANTOS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1885
2 A medical device with a moderate to high risk that requires special controls. 5568