Widex - WIDEX MAGNIFY MBR3D M10 (Deep Blue) - Widex A/S

Duns Number:309843613

Device Description: WIDEX MAGNIFY MBR3D M10 (Deep Blue)

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More Product Details

Catalog Number

21010380

Brand Name

Widex

Version/Model Number

MAGNIFY MBR3D M10

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)

-

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

OSM

Product Code Name

Hearing aid, air conduction with wireless technology

Device Record Status

Public Device Record Key

e6db326a-9d88-47e0-ba70-4a5568db0a59

Public Version Date

November 03, 2021

Public Version Number

1

DI Record Publish Date

October 26, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WIDEX A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 191
2 A medical device with a moderate to high risk that requires special controls. 5429