WiscMed

Primary DI
00850009819000
Brand
WiscMed
Company
WISC MED, LLC
Model
Wispr24701
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.
Published
2020-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERAOtoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850009819000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009819000008500098190008500098190000850009819000

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, directA portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6087297234wiscmedsupport@wiscmed.com

Regulatory Flags#

DUNS number
070666290
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850009819017WiscMedspec1-3002020-03-27
00850009819024WiscMedspec1-962020-03-27

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Primary DI, Brand, Company table
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20884392954455Safety 1stDOREL JUVENILE GROUP, INC.ERA2023-10-15
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