zumax

Basic Information

• Brand Name: zumax
• Primary DI: 06945095511007
• Version / Model: DM6
• 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: 3
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: b09588ae-1566-4ae3-b774-908426e22ab9

Device Description

3.5V Coaxial Ophthalmoscope

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
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	886.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46786	Direct ophthalmoscope	An electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 15 times magnification. It consists of a main unit (commonly referred to as the head) with a built-in light source directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers; a dedicated power supply handpiece may be included with the head.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06945095511007	GS1