Catalog Number

91868

Brand Name

Baha

Version/Model Number

91868

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

K955713

Product Code

LXB

Product Code Name

Hearing aid, bone conduction

Public Device Record Key

aa1dfaed-c0d9-4b67-a482-4f333405f7ef

Public Version Date

December 24, 2018

Public Version Number

3

DI Record Publish Date

July 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-