DEVICE: Zoom Slit Lamp (04562230691640)

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Device Identifier (DI) Information

Zoom Slit Lamp
RS-1000

RIGHT MFG. CO., LTD.
04562230691640
GS1
1
The RS-1000 zoom slit lamps are designed for ophthalmic observation and microphotography. These slit lamps feature zoom stereoscopic converging microscopes that can be used for ophthalmic observation. This equipment is intended for use by medical doctors and optometrists. Each instrument consists primarily of the main unit and the illumination power supply unit. consisting of: ・Zoom Slit Lamp RS-1000 Main Body ・Breath Plate ・Eyepiece 12.5X ・Eyepiece with Reticle 12.5X ・Wooden Table top with chin rest ・Power supply for Illumination P-300R ・UL Power supply Cord Hospital Grade(120V)
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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
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 40 Degrees Celsius
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
Weight: 13 Kilogram
Depth: 405 Millimeter
Height: 735 Millimeter
Width: 330 Millimeter
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Device Status

In Commercial Distribution
July 13, 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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None
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Production Identifier(s) in UDI

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Customer Contact

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+81223593113
righton.service@rightmfg.co.jp
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