Catalog Number

-

Brand Name

NA

Version/Model Number

S0264-31

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

K153391

Product Code

LXB

Product Code Name

Hearing aid, bone conduction

Public Device Record Key

3a9eece7-c11d-4047-a1f5-a88b5805d6ab

Public Version Date

April 06, 2020

Public Version Number

4

DI Record Publish Date

October 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-