DEVICE: DIGITAL MEDICAL SCOPE (04987669101070)
Device Identifier (DI) Information
DIGITAL MEDICAL SCOPE
DS-10 Control Unit
In Commercial Distribution
NIDEK CO.,LTD.
DS-10 Control Unit
In Commercial Distribution
NIDEK CO.,LTD.
The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be used to record digital photographs and video of
the body.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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| Yes | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 36292 | Endoscope camera adaptor |
An optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. This is a reusable device.
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Active | false |
| 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.
|
Active | false |
| 47160 | Dermatoscope, digital |
An electrically-powered, hand-held instrument intended to be used for the microscopic examination of the external skin layers through the production of digital images (i.e. without direct optical view). The device has a built-in light source(s) and an electronic magnification system that provides the user with digital images of the structures of the epidermis and epidermal-dermal junction for visualization during dermatoscopy (also known as dermascopy). This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).
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Active | false |
| 10551 | Ophthalmic fundus camera |
An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FTT | Camera, Still, Surgical |
| ERA | Otoscope |
| FSP | Loupe, Diagnostic/Surgical |
| FXF | Speculum, Illuminated |
| HKI | Camera, Ophthalmic, Ac-Powered |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
ff5f5ac8-5a21-4ef8-b382-bb5d18383244
May 10, 2021
4
January 31, 2017
May 10, 2021
4
January 31, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-223-9044
info@nidek.com
info@nidek.com