NA

Basic Information

• Brand Name: NA
• Primary DI: 04582275270068
• Version / Model: COLORDX CCT HD
• Company Name: KONAN MEDICAL USA, INC.
• Labeler DUNS: 788439219
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-15
• Public Version: 1
• Public Version Date: 2023-06-23
• Public Version Status: New
• Public Device Record Key: 4138f164-bfa4-4dd3-8c34-283d038f8670

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: 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
HIT	Tester, color vision	Ophthalmic	886.1170	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32687	Colour discrimination tester	An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured plates which patients with colour vision deficiency would perceive as being of one colour), used for evaluating colour vision.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04582275270068	GS1