ADHEAR User Kit, Terra Brown - Audio Processor Kit (without headband) - Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Duns Number:300764032

Device Description: Audio Processor Kit (without headband)

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More Product Details

Catalog Number

-

Brand Name

ADHEAR User Kit, Terra Brown

Version/Model Number

38203

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LXB

Product Code Name

Hearing Aid, Bone Conduction

Device Record Status

Public Device Record Key

342ab12b-5c4e-4fe0-88e2-652a2c5e83b1

Public Version Date

September 16, 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