DEVICE: REFRACTOR (04987669100820)

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Device Identifier (DI) Information

REFRACTOR
RT-5100

NIDEK CO.,LTD.
04987669100820
GS1
1
The NIDEK REFRACTOR Model RT-5100 is a computerized refractor used for subjective refraction in connection with the NIDEK AUTO REFRACTOMETER (AR), AUTO REF/KERATOMETER (ARK), AUTO REF/KER/TONOMETER (RKT), or AUTO LENSMETER (LM). The RT-5100 includes a refractor head, control box, relay box, and printer.
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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
Phoropter A mechanical ophthalmic device that is used during an ophthalmic examination; typically to determine a patient's prescription for glasses. It consists of two large, disk-like housings, joined together, that each contain a built-in paternoster works consisting of a large number of different lenses of differing strengths used to measure the refraction of the eye; it is a mechanized set of trial lenses. It is placed in front of the patient's eyes and viewing through the phoropter the patient is asked to read a Snellen eye chart placed at a preset distance. The optometrist changes the lenses and other settings, while asking the patient for subjective feedback on which settings give best vision.
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FDA Product Code

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Product Code Product Code Name
HKN Refractor, Manual, Non-Powered, Including Phoropter
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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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 10, 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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None
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Production Identifier(s) in UDI

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Customer Contact

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1-800-223-9044
info@nidek.com
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