Catalog Number

93088

Brand Name

Baha

Version/Model Number

93088

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2019

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

K110996,K110996

Product Code

LXB

Product Code Name

Hearing aid, bone conduction

Public Device Record Key

ad45e899-b3dd-4bd5-a539-bc1e3bd6c3ad

Public Version Date

September 17, 2020

Public Version Number

4

DI Record Publish Date

July 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-