DEVICE: KOWA GENESIS-Df (04987646800583)

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Device Identifier (DI) Information

KOWA GENESIS-Df
K9L51BK

KOWA COMPANY,LTD.
04987646800583
GS1
1
KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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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
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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FDA Product Code

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Product Code Product Code Name
HKI Camera, Ophthalmic, Ac-Powered
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between -15 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Power supply unit Weight: 1930Grams, Width: 180mm, Depth: 300mm, Height: 230mm
Device Size Text, specify: Camera unit Weight: 1070Grams, Width: 74.5mm, Depth: 197mm, Height: 278.5mm
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Device Status

In Commercial Distribution
September 16, 2016

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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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No
No
None
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Production Identifier(s) in UDI

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No CLOSE

Customer Contact

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No Customer Contact currently defined
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