Catalog Number

-

Brand Name

Otomag™ Alpha (M) Magnetic Implant

Version/Model Number

S0521-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 24, 2018

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

K132189

Product Code

LXB

Product Code Name

Hearing aid, bone conduction

Public Device Record Key

b1105265-d5ad-4952-9e3d-3f9297baedb4

Public Version Date

February 15, 2019

Public Version Number

4

DI Record Publish Date

April 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-