HANDHELD REF / KERATOMETER

GUDID 04987669100769

The NIDEK HANDHELD REF/KERATOMETER, HandyRef-K, measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. The keratometer measures the corneal curvature radius (corneal refractive power) in the steepest and flattest meridian directions, cylinder axis, and corneal cylindrical power. This device is a hand-held model that allows measurement of children who cannot hold their head on the stationary chinrest, bed-ridden patients or patients in an operating room.

NIDEK CO.,LTD.

Ophthalmic refractometer, automated

• Primary Device ID: 04987669100769
• NIH Device Record Key: b9ba98ea-703d-4b07-91bc-aaa0790e8e9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANDHELD REF / KERATOMETER
• Version Model Number: HandyRef-K
• 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	04987669100769 [Primary]

FDA Product Code

• HKO: Refractometer, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2018-04-20

Devices Manufactured by NIDEK CO.,LTD.

• 04987669200018 - A-scan probe: 2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.
• 04987669200049 - Pachymetry probe (45° fixed type): 2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.
• 04987669200070 - A-scan probe: 2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
• 04987669200094 - Pachymetry probe: 2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
• 04987669200100 - Pachymetry probe (45° fixed type): 2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
• 04987669200117 - A-scan probe: 2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-500.
• 04987669200780 - IOL-Station: 2023-07-18 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica
• 04987669100844 - IOL-Station: 2023-06-20 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica