Duns Number:309843613
Device Description: WIDEX MAGNIFY MBR3D M10 (Deep Blue)
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
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
e6db326a-9d88-47e0-ba70-4a5568db0a59
Public Version Date
November 03, 2021
Public Version Number
1
DI Record Publish Date
October 26, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |