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Barcode (UDI): 4045396010710
Catalog No: 10533
Product Type: Medical Device
GMDN: Outer ear otoscope (12849)
Regulation: 2017/745
Description: A battery-powered, hand-held, device (i.e., non-endoscopic rigid type) primarily designed for examining the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening during ear/nose/throat (ENT) treatments. 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.