Duns Number:157412271
Device Description: Signia Siemens HA ACE 5PX DRD Hearing Aid
Catalog Number
10935984
Brand Name
Signia Siemens
Version/Model Number
HA ACE 5PX DRD
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 13, 2020
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
ESD
Product Code Name
Hearing Aid, Air Conduction
Public Device Record Key
ea01b48e-3288-4273-8fd1-bc047bfda821
Public Version Date
November 16, 2020
Public Version Number
4
DI Record Publish Date
June 19, 2016
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 | 1885 |
2 | A medical device with a moderate to high risk that requires special controls. | 5568 |