Duns Number:611658795
Device Description: Inductive Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
Catalog Number
IPR01XX
Brand Name
Earlens Processor
Version/Model Number
IPR01XX
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)
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
dd20b4f2-254b-40df-a7f9-74d0e82b3a65
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 |