MORIA

Basic Information

• Brand Name: MORIA
• Primary DI: 03700483620081
• Version / Model: ACP tubing set x10
• Catalog Number: 19192
• Company Name: MORIA SA
• Labeler DUNS: 275937506
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-27
• Public Version: 1
• Public Version Date: 2024-01-04
• Public Version Status: New
• Public Device Record Key: 52730b70-ec3f-47e9-b538-826592c6ba6e

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64551	Corneal resection pressurization tubing set	A dedicated collection of tubing and associated devices (e.g., connectors, stopcock, syringe) intended to connect a corneal resection pump to a corneal resection holder, so that fluid (saline) introduced within the tubing line, and in contact with the corneal graft mounted on the holder, is pressurized equivalent to that of the anterior chamber of the eye during graft preparation prior to transplantation. The pump generates a controlled positive pressure of air, which is intended to exert a force on fluid (saline) within the tubing; the pressurized air is not intended to directly contact the graft. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03700483620098	GS1		10	In Commercial Distribution
Primary	03700483620081	GS1