Identity
- Trade Name
- Verifit Skull Simulator FDA UDI
- Generic Name
- Bone vibrator mechanical coupler FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- VA-300 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B161VA3000 FDA UDI
- FDA Product Code
- ETW FDA UDI
- GMDN Term
- Bone vibrator mechanical coupler FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone vibrator mechanical coupler
Verifit Skull Simulator by Etymonic Design Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Etymonic Design Incorporated
Sources (1)
- FDA UDI 193d3a62-a714-4de2-9f8c-3142d5df54a5 34 fields · synced May 31, 2026