Duns Number:611658795
Device Description: Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR-Brown. This is for quantity of 2.
Catalog Number
PREL1XX2
Brand Name
Earlens Processor
Version/Model Number
PREL1XX2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 03, 2017
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
-
Product Code
PLK
Product Code Name
Tympanic Membrane Direct Contact Hearing Aid
Public Device Record Key
20fc194e-d7e2-492c-93a1-edcba883f13d
Public Version Date
March 25, 2019
Public Version Number
7
DI Record Publish Date
June 01, 2017
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 |