Identity
- Trade Name
- WiscMed FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Wispr24701 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850009819000 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Otoscope, direct FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 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
Yes
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
Yes
FDA UDI
Category: Otoscope, direct
WiscMed by Wiscmed, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Wiscmed, Llc
Sources (1)
- FDA UDI 8aef5cde-6993-45f6-a52d-fd01c6223b2b 34 fields · synced May 31, 2026