Catalog Number

-

Brand Name

ADHEAR Configuration Software 1.0 DVD

Version/Model Number

52275

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 22, 2021

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172460

Product Code

LXB

Product Code Name

Hearing Aid, Bone Conduction

Public Device Record Key

5b6f819b-cb44-422b-ac0c-985be33f5dd3

Public Version Date

September 15, 2022

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-