Duns Number:611658795
Device Description: Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this prod Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this product box.
Catalog Number
TLEL1LR
Brand Name
Earlens Tympanic Lens
Version/Model Number
TLEL1LR
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 02, 2021
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
c28a838d-b46c-4801-818e-2a93fc0f9649
Public Version Date
September 09, 2021
Public Version Number
9
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 |