Duns Number:101877157
Device Description: This is a stock/universal fit hearing aid similar in size to a CIC (Custom In the Canal) . This is a stock/universal fit hearing aid similar in size to a CIC (Custom In the Canal) . The device is used for mild to moderate hearing loss. This is non-programmable in the field and adjustments ONLY made by the factory for a patient's hearing loss and related factors.
Catalog Number
-
Brand Name
RXEars
Version/Model Number
RXi
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 24, 2022
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
09afaf13-eb52-43a4-b574-8f3112b86335
Public Version Date
November 01, 2022
Public Version Number
1
DI Record Publish Date
October 24, 2022
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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |