Duns Number:157412271
Device Description: Siemens UNITY 3 HDA300 HEADSET
Catalog Number
10825966
Brand Name
Siemens
Version/Model Number
UNITY 3 HDA300 HEADSET
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 05, 2017
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
EWO
Product Code Name
Audiometer
Public Device Record Key
f60e7aba-9d39-415f-944c-5467fac8948c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 08, 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 |