Widex - Widex mind330 M3-X ITE (Dark brown ) Telecoil - Widex A/S

Duns Number:309843613

Device Description: Widex mind330 M3-X ITE (Dark brown ) Telecoil

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More Product Details

Catalog Number

8 265 0100 027

Brand Name

Widex

Version/Model Number

M3-X

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

38d9b226-4281-409e-a129-b8ce433825fc

Public Version Date

October 06, 2020

Public Version Number

3

DI Record Publish Date

September 01, 2016

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