MorTan

Basic Information

• Brand Name: MorTan
• Primary DI: B090MT20000
• Version / Model: MT2000
• Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.
• Labeler DUNS: 017535668
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-25
• Public Version: 1
• Public Version Date: 2025-07-03
• Public Version Status: New
• Public Device Record Key: aff8c3b2-ed23-4af4-8287-ebb975f87505

Device Description

The Morgan medi-FLOW Lens

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	886.4360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65415	Eye irrigation shield, single-use	A device intended to be used with an eye irrigation kit/system to direct irrigation solution to the surface of the eye and allow the solution to gently lavage the surface of the eye (e.g., to flush the cornea and sclera of irritating particulates/chemicals). It is a curved/cup-like device, intended to be placed over the eye surface, with a port to allow entry of the irrigation solution; it may include a length of tubing. It is intended to be connected to an irrigation solution reservoir/pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B090MT20001	HIBCC		12	In Commercial Distribution
Primary	B090MT20000	HIBCC