ADHEAR Headband, beige, bilateral - Audio Processor Headband - Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Duns Number:300764032

Device Description: Audio Processor Headband

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More Product Details

Catalog Number

-

Brand Name

ADHEAR Headband, beige, bilateral

Version/Model Number

39607

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K172460

Product Code Details

Product Code

LXB

Product Code Name

Hearing Aid, Bone Conduction

Device Record Status

Public Device Record Key

cad1718d-6146-4566-8e66-717094db7e48

Public Version Date

September 15, 2022

Public Version Number

3

DI Record Publish Date

November 08, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MED-EL ELEKTROMEDIZINISCHE GERÄTE GESELLSCHAFT M.B.H." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 70
3 A medical device with high risk that requires premarket approval 773