Duns Number:157412271
Device Description: Signia Siemens HA PURE 13 BT 3PX BG Hearing Aid
Catalog Number
10936595
Brand Name
Signia Siemens
Version/Model Number
HA PURE 13 BT 3PX BG
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 10, 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
OSM
Product Code Name
Hearing Aid, Air Conduction With Wireless Technology
Public Device Record Key
c81965b2-63fe-4250-912d-44d9f07a166b
Public Version Date
November 11, 2020
Public Version Number
3
DI Record Publish Date
May 08, 2018
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 |