audifon - BTE-TRT - audifon GmbH & Co. KG

Duns Number:344064407

Device Description: BTE-TRT

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More Product Details

Catalog Number

003610-2527-332-1720

Brand Name

audifon

Version/Model Number

switch TRT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2016

Issuing Agency

In HIBCC

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

K091552

Product Code Details

Product Code

ESD

Product Code Name

Hearing Aid, Air Conduction

Device Record Status

Public Device Record Key

5d9db57a-9ae1-4ad6-8220-dc39320a380d

Public Version Date

October 06, 2020

Public Version Number

5

DI Record Publish Date

November 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AUDIFON GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 262
2 A medical device with a moderate to high risk that requires special controls. 166