FDA.reportPublic FDA data

KOWA nonmyd 8

Primary DI
04987646807575
Brand
KOWA nonmyd 8
Company
KOWA COMPANY,LTD.
Model
K9L61K
Device description
The KOWA nonmyd 8 is intended for use with retinal image capturing without mydriatic.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKICamera, Ophthalmic, Ac-Powered
PJZCamera, Ophthalmic, General-Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2
PJZCamera, Ophthalmic, General-UseOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987646807575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987646807575049876468075754987646807575

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fundus cameraAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth504Millimeter
Height548Millimeter
Weight21Kilogram
Width310Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
692281073
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987646810476KOWA SL-19SL192BK/W2024-10-08
04987646810223KOWA SL-19SL191BK/W2023-01-10
04987646810032KOWA SL-19SL191K/W2022-12-07
04987646810049KOWA SL-19SL191K/A2022-12-07
04987646810056KOWA SL-19SL191K/G2022-12-07
04987646810063KOWA SL-19SL191K/P2022-12-07
04987646810070KOWA SL-19SL191K/B2022-12-07
04987646804031KOWA SL-15SL150K2016-09-16
04987646806905KOWA SL-17SL170K/W2016-09-16
04987646806912KOWA SL-17SL170K/A2016-09-16
04987646806929KOWA SL-17SL170K/G2016-09-16
04987646806936KOWA SL-17SL170K/P2016-09-16
04987646809128KOWA nonmyd AFK9L64K2020-01-15
04987646807728KOWA DR-1αDE2K2019-06-10
04987646808923KOWA VK-2sVK28K2019-06-10
04987646808930KOWA VK-2sVK28UE2019-06-10
04987646808947KOWA VK-2sVK28U2E2019-06-10
04987646805113KOWA AP-7000FT10K2019-01-08
04987646800583KOWA GENESIS-DfK9L51BK2016-09-16
04987646800606KOWA nonmyd a-DIIIK9L58K2018-02-23

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