Auto Ref-Keratometer HRK-8000A

Basic Information

• Brand Name: Auto Ref-Keratometer HRK-8000A
• Primary DI: 08800019600152
• Version / Model: HRK-8000A
• Catalog Number: HRK-8000A
• Company Name: Huvitz Co., Ltd.
• Labeler DUNS: 688154202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-10
• Public Version: 1
• Public Version Date: 2019-05-20
• Public Version Status: New
• Public Device Record Key: 8a2a7d67-da43-421b-b373-605912efd7bf

Device Description

The Auto Ref/Keratometer is intended to be used to measure the refractive power of the eye

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
36387	Ophthalmic refractometer, manual	A manually-operated ophthalmic device designed to measure the refractive error of the eye (the inaccuracies of focusing of light upon the retina); typically the measurements are made in dioptres (the reciprocal of the focal length of the lens expressed in metres). Using this information the optometrist can calculate the lens prescription needed to correct the patient's refractive error. With advanced instruments the measurements are made automatically with printed verification.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800019600152	GS1

Customer Contacts

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