Duns Number:244780581
Device Description: An optional accessory to the Audioscan Verifit VF-2 or Verifit VF-1 hearing aid analyzer o An optional accessory to the Audioscan Verifit VF-2 or Verifit VF-1 hearing aid analyzer or hearing instrument test (HIT) system. The VA-300 Verifit Skull Simulator is a measurement coupler operating in place of a standard acoustic coupler to facilitate measurement of the vibrational output produced by a bone conduction hearing aid. The device is intended as a direct substitute for the acoustic measurement coupler and uses the identical micro-power electrical interface.
Catalog Number
-
Brand Name
Verifit Skull Simulator
Version/Model Number
VA-300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
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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
ETW
Product Code Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Public Device Record Key
193d3a62-a714-4de2-9f8c-3142d5df54a5
Public Version Date
May 10, 2019
Public Version Number
1
DI Record Publish Date
May 02, 2019
Package DI Number
B161VA3003
Quantity per Package
1
Contains DI Package
B161VA3000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |