DEVICE: DIGITAL MEDICAL SCOPE (04987669101032)

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Device Identifier (DI) Information

DIGITAL MEDICAL SCOPE
DS-10E

NIDEK CO.,LTD.
04987669101032
GS1
1
DS-10E is a digital hand-held otoscope used to record digital photographs and video of the human ear’s canal and tympanic membrane.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Outer ear otoscope 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.
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FDA Product Code

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Product Code Product Code Name
ERA Otoscope
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
January 31, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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1-800-223-9044
info@nidek.com
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