DEVICE: LED SLIT LAMP (04562230697062)

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Device Identifier (DI) Information

LED SLIT LAMP
MW50D

RIGHT MFG. CO., LTD.
04562230697062
GS1
1
The MW50D LED SLIT LAMPs are designed for ophthalmic observation and microphotography. These slit lamps feature 5 step magnification microscopes that can be used for ophthalmic observation. Consisting of; ・LED slit lamp MW50D Main Body ・Eyepiece 12.5X for MW50 ・Eyepiece 12.5X with Reticle for MW50 ・Metal Table top with Chin rest for MW50 ・Power supply Unit for MW50 ・Power supply CordHospital Grade(120V) ・Dust Cover(Righton Logo)
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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
Ophthalmic slit lamp, examination A mains electricity (AC-powered), ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).
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FDA Product Code

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Product Code Product Code Name
HJO Biomicroscope, Slit-Lamp, Ac-Powered
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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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 55 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Weight: 14 Kilogram
Height: 678.5 Millimeter
Depth: 387 Millimeter
Width: 350 Millimeter
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Device Status

In Commercial Distribution
September 05, 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
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Secondary DI

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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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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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