Catalog Number

21004684

Brand Name

Widex

Version/Model Number

M-XP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

OSM

Product Code Name

Hearing aid, air conduction with wireless technology

Public Device Record Key

2454be11-a82b-4f34-b4e4-2c58ae867bb0

Public Version Date

April 05, 2021

Public Version Number

1

DI Record Publish Date

March 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-