HANDHELD REF / KERATOMETER

Basic Information

• Brand Name: HANDHELD REF / KERATOMETER
• Primary DI: 04987669100769
• Version / Model: HandyRef-K
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-20
• Public Version: 4
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: b9ba98ea-703d-4b07-91bc-aaa0790e8e9b

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKO	Refractometer, Ophthalmic	Ophthalmic	886.1760	1
HLQ	Keratoscope, Ac-Powered	Ophthalmic	886.1350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12811	Bench-top keratometer	A bench-top, mains electricity (AC-powered) ophthalmic instrument designed to measure the curvature of the anterior surface of the cornea, particularly for determining the presence, extent, and axis of astigmatism (an error of refraction in the eye due to the cornea being unequally curved in different directions, so that rays of light in different meridians cannot be brought to focus together on the retina). It actually measures the radius of curvature in millimetres but typically displays it in dioptres. It is used mainly for contact lens fitting and for intraocular lens power determination prior to cataract surgery. This device is also known as an ophthalmometer.	No	Active
36386	Automated ophthalmic refractometer	An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987669100769	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]