Duns Number:117929555
Device Description: Ear Wax Removal System. View and safely clean your ear canal. The bebird cleaning rod wir Ear Wax Removal System. View and safely clean your ear canal. The bebird cleaning rod wireless connects to your apple or android phone or tablet allowing the user to see high resolution images of their outer ear canal.
Catalog Number
HVRS
Brand Name
bebird
Version/Model Number
W3-WM-BK
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
ERA
Product Code Name
Otoscope
Public Device Record Key
ce85f8b4-22d6-49b5-a3e9-6f9be06dc40c
Public Version Date
August 30, 2021
Public Version Number
1
DI Record Publish Date
August 20, 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 | 1 |