REFRACTOR

GUDID 04987669100820

The NIDEK REFRACTOR Model RT-5100 is a computerized refractor used for subjective refraction in connection with the NIDEK AUTO REFRACTOMETER (AR), AUT

NIDEK CO.,LTD.

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• Primary Device ID: 04987669100820
• NIH Device Record Key: fe729852-a220-49f0-9250-1b632f54d24a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFRACTOR
• Version Model Number: RT-5100
• Company DUNS: 690635461
• Company Name: NIDEK CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987669100820 [Primary]

FDA Product Code

• HKN: Refractor, Manual, Non-Powered, Including Phoropter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-10

On-Brand Devices [REFRACTOR]

• 04987669100820: The NIDEK REFRACTOR Model RT-5100 is a computerized refractor used for subjective refraction in
• 04987669100813: The NIDEK REFRACTOR Model RT-3100 is a computerized refractor used for subjective refraction wit
• 04987669101445: The RT-6100 is a motorized refractor for subjective refraction designed to be connected with oth
• 04987669101711: NIDEK Model RT-600 has been developed to renovate the conventional refractor, assuming a new asp