zumax

Basic Information

• Brand Name: zumax
• Primary DI: 06945095531982
• Version / Model: R4180-LED
• Company Name: Zumax Medical Co., LTD
• Labeler DUNS: 421348837
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-27
• Public Version: 1
• Public Version Date: 2018-09-27
• Public Version Status: New
• Public Device Record Key: 8a16019e-8b6e-4b4e-9d5e-48559cce85e6

Device Description

Streak Retinoscope LED bulb,3.5V

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: No
• Has Lot/Batch Number: Yes
• 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
HKM	Retinoscope, Battery-Powered	Ophthalmic	886.1780	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32712	Retinoscope, battery-powered	A battery-powered, hand-held, ophthalmic instrument that is used to measure the refractive errors of the eye through the projection of a beam of light into the eye, and the observation of the movement of the illuminated area on the retinal surface and of the refraction of the emergent rays. The batteries may be of the rechargeable type, and are housed within the handle of the instrument. Also known as a skiascope and the method as sciascopy.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06945095531982	GS1