Duns Number:300764032
Device Description: Audio Processor
Catalog Number
-
Brand Name
SONNET 2 EAS CPU Me1523 black
Version/Model Number
34940
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
P000025,P000025,P000025,P000025,P000025
Product Code
PGQ
Product Code Name
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
Public Device Record Key
c78f3a00-528e-4ce7-9c4c-4790ef94f188
Public Version Date
April 14, 2022
Public Version Number
4
DI Record Publish Date
October 18, 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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 70 |
| 3 | A medical device with high risk that requires premarket approval | 773 |