Duns Number:078497467
Device Description: Wearable air-conduction hearing aid - wearable sound-amplifying device that is intended to Wearable air-conduction hearing aid - wearable sound-amplifying device that is intended to compensate for impaired hearing.
Catalog Number
-
Brand Name
Beurer
Version/Model Number
HA50 (Art.- No. 641.71)
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ESD
Product Code Name
Hearing Aid, Air Conduction
Public Device Record Key
d639952f-53db-41d9-a5ef-7d16989048d8
Public Version Date
October 06, 2020
Public Version Number
4
DI Record Publish Date
June 12, 2017
Package DI Number
10853879007024
Quantity per Package
8
Contains DI Package
00853879007027
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |
| U | Unclassified | 2 |