DEVICE: KOWA nonmyd 8s (04987646807612)
Device Identifier (DI) Information
KOWA nonmyd 8s
K9L63K
In Commercial Distribution
KOWA COMPANY,LTD.
K9L63K
In Commercial Distribution
KOWA COMPANY,LTD.
The KOWA nonmyd 8s is intended for use with retinal image capturing without mydriatic.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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 |
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PJZ | Camera, Ophthalmic, General-Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 35 Degrees Celsius |
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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Height: 548 Millimeter |
Depth: 504 Millimeter |
Width: 310 Millimeter |
Weight: 21 Kilogram |
Device Record Status
d50a24a8-c1e1-4eb2-9b69-5d825d774654
March 29, 2018
2
September 16, 2016
March 29, 2018
2
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined