ONE

Basic Information

• Brand Name: ONE
• Primary DI: 03700483602209
• Version / Model: ONE-MENDEZ RING, 12MM
• Catalog Number: 17250X1
• Company Name: MORIA SA
• Labeler DUNS: 275937506
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-28
• Public Version: 1
• Public Version Date: 2024-01-05
• Public Version Status: New
• Public Device Record Key: a8b8e1a4-f04b-4833-a6b4-2616dd95405a

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
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64447	Ophthalmic angular gauge, single-use	A non-powered, hand-held, ophthalmic surgical device designed to measure angular distances radially around the surface of the eye [e.g., during intraocular lens (IOL) implantation/alignment]. Also referred to as a Mendez degree gauge, it consists of a handle with a distal ring which includes angle degree markings; it may include blunt teeth on the underside of the ring to allow it to grip to the eye during use. It is not intended for use as a marker. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03700483602599	GS1		1	In Commercial Distribution
Primary	03700483602209	GS1