Duns Number:611658795
Device Description: Kit containing Right Light Tip & Processor Assembly,Right Tympanic Lens,Charger.Processor Kit containing Right Light Tip & Processor Assembly,Right Tympanic Lens,Charger.Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown
Catalog Number
MKEL1R
Brand Name
Earlens Light Driven Hearing Aid, Monaural, Right
Version/Model Number
MKEL1R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 31, 2020
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PLK
Product Code Name
Tympanic Membrane Direct Contact Hearing Aid
Public Device Record Key
6c9b0fe9-f358-48c7-b5b5-0efe155cdfb5
Public Version Date
January 31, 2020
Public Version Number
8
DI Record Publish Date
September 24, 2016
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |