AccessGUDID - DEVICE: Verifit Skull Simulator (B161VA3000)

GUDID

Device Identifier (DI) Information

Brand Name: Verifit Skull Simulator
Version or Model: VA-300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Etymonic Design Incorporated

Primary DI Number: B161VA3000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 244780581 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36803	Bone vibrator mechanical coupler	A device designed to present a specific mechanical impedance to a bone vibrator, applied with a specific static force and equipped with a mechano-electric transducer, to enable an alternating force level at the point of contact between vibrator and mechanical coupler to be determined. Also known as an artificial mastoid, it provides a mechanical load to a bone vibrator that approximates that of the average human mastoid process. The standard (IEC 60318-6) specifies such a device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 20 and 50 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 81 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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