Duns Number:070666290
Device Description: The Wispr is general purpose handheld digital otoscope that provides a detailed view of th The Wispr is general purpose handheld digital otoscope that provides a detailed view of the external auditory canal and tympanic membrane. The Wispr utilizes a nano camera (shrouded by a single-use speculum), LED fiber optic illumination, and a display screen that allows the user to view, evaluate and save images and video for further review. The primary user interface is a touch screen display and single push button. A USB port is provided that allows for off-line download of image and video files. The Wispr is designed to attach to current industry standard otoscope power handles.
Catalog Number
-
Brand Name
WiscMed
Version/Model Number
Wispr24701
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ERA
Product Code Name
Otoscope
Public Device Record Key
8aef5cde-6993-45f6-a52d-fd01c6223b2b
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
March 27, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |