Duns Number:338454995
Device Description: MIDDLE EAR ANALYZER / AUDIOMETER.Viola Plus is a middle ear analyzer / audiometer, capable MIDDLE EAR ANALYZER / AUDIOMETER.Viola Plus is a middle ear analyzer / audiometer, capable of performing tympanometry and acoustic reflex tests in sequence and automatically, reflex test decay; pure tone and speech audiometry using air and bone conduction.
Catalog Number
10374
Brand Name
VIOLA
Version/Model Number
VIOLA PLUS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
PTO
Product Code Name
Tester, Auditory Impedance, Exempt
Public Device Record Key
c3ab5867-a7f9-412a-a2f1-afc9db539e3c
Public Version Date
June 05, 2018
Public Version Number
3
DI Record Publish Date
September 17, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |