Duns Number:061455809
Device Description: Charger for ZPower Rechargeable System for Hearing Aids
Catalog Number
9-05-00339-5
Brand Name
ZPower Rechargeable System for Hearing Aids
Version/Model Number
Z602-312
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ESD
Product Code Name
Hearing Aid, Air Conduction
Public Device Record Key
5542a9b8-9acc-4b3b-836d-ed617d091bc4
Public Version Date
February 06, 2020
Public Version Number
2
DI Record Publish Date
July 24, 2018
Package DI Number
10811204030215
Quantity per Package
1
Contains DI Package
00811204030218
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 59 |