Catalog Number

-

Brand Name

Otomag™ Alpha 2 Sound Processor

Version/Model Number

S0415-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

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

K100193

Product Code

LXB

Product Code Name

Hearing aid, bone conduction

Public Device Record Key

68fe5f8a-f56e-43a8-b35a-259fc6793eac

Public Version Date

April 06, 2020

Public Version Number

4

DI Record Publish Date

September 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-