Catalog Number

-

Brand Name

ADHEAR Audio Processor (701), Simply Black, lock

Version/Model Number

40430

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

-

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

K172460

Product Code

LXB

Product Code Name

Hearing Aid, Bone Conduction

Public Device Record Key

c1e570c0-ceb9-4c11-b564-162c6f97f957

Public Version Date

September 15, 2022

Public Version Number

2

DI Record Publish Date

July 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-