Duns Number:300764032
Device Description: Audio Processor Fitting Kit
Catalog Number
-
Brand Name
AP Fitting Kit Amadé
Version/Model Number
51068
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 24, 2021
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
P990052
Product Code
MPV
Product Code Name
Implant, Hearing, Active, Middle Ear, Partially Implanted
Public Device Record Key
2cb920cd-679a-43ca-b723-82544c6e7413
Public Version Date
September 15, 2022
Public Version Number
6
DI Record Publish Date
September 22, 2014
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 |