FDA UDI
In Commercial Distribution
🇺🇸 United States
WiscMed
DI: 00850009819000
·
Model: Wispr24701
·
WISC MED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WiscMed
- Primary DI
- 00850009819000
- Version / Model
- Wispr24701
- Company Name
- WISC MED, LLC
- Labeler DUNS
- 070666290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-27
- Public Version
- 2
- Public Version Date
- 2021-05-10
- Public Version Status
- Update
- Public Device Record Key
- 8aef5cde-6993-45f6-a52d-fd01c6223b2b
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ERA | Otoscope | Ear, Nose, Throat | 874.4770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12849 | Otoscope, direct | An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850009819000 | GS1 |
Customer Contacts
- Phone
- 6087297234
- [email protected]