Catalog Number

-

Brand Name

NA

Version/Model Number

S0268-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K100193

Product Code

LXB

Product Code Name

Hearing aid, bone conduction

Public Device Record Key

4a758ecf-eab0-406d-bf44-b8d6a282e056

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-