Duns Number:300764032
Device Description: Audio Processor Battery Pack
Catalog Number
-
Brand Name
Children's Battery Pack red 27 cm
Version/Model Number
04039
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,P000025,P000025,P000025
Product Code
MCM
Product Code Name
Implant, Cochlear
Public Device Record Key
57bdfb09-d092-4438-8a04-2594e5317977
Public Version Date
August 24, 2022
Public Version Number
6
DI Record Publish Date
September 23, 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 |