Duns Number:338454995
Device Description: AUDIOMETER.Piccolo Plus Aero is a portable audiometer that can be controlled from a Window AUDIOMETER.Piccolo Plus Aero is a portable audiometer that can be controlled from a Windows computer or iPad.Available exams: pure tone audiometry via air conduction and bone conduction.
Catalog Number
10330
Brand Name
PICCOLO
Version/Model Number
PICCOLO PLUS AERO
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
EWO
Product Code Name
Audiometer
Public Device Record Key
27e93f57-5add-4cb7-9760-3ea33e0a5e73
Public Version Date
March 29, 2018
Public Version Number
2
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 |