Duns Number:611658795
Device Description: Inductive Kit containing Left and Right Ear Tip & Processor AssembliesLeft and Right Tympa Inductive Kit containing Left and Right Ear Tip & Processor AssembliesLeft and Right Tympanic LensChargerProcessor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
Catalog Number
IBK01
Brand Name
Earlens Contact Hearing Solution, Binaural
Version/Model Number
IBK01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K182480
Product Code
PLK
Product Code Name
Tympanic Membrane Direct Contact Hearing Aid
Public Device Record Key
42be9ed5-cdbc-4750-9475-e983aac2e105
Public Version Date
May 07, 2020
Public Version Number
2
DI Record Publish Date
May 06, 2019
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 |