Bernafon - AO9 MNR T R SABE/MSIL ALIGO 9 GPL - Bernafon AG

Duns Number:480002286

Device Description: AO9 MNR T R SABE/MSIL ALIGO 9 GPL

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More Product Details

Catalog Number

-

Brand Name

Bernafon

Version/Model Number

222096

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

-

Product Code Details

Product Code

KLW

Product Code Name

Masker, tinnitus

Device Record Status

Public Device Record Key

93545790-ee7f-41e7-8427-bc5a0643c429

Public Version Date

December 25, 2020

Public Version Number

1

DI Record Publish Date

December 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BERNAFON AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 198
2 A medical device with a moderate to high risk that requires special controls. 1529