ONE

Basic Information

• Brand Name: ONE
• Primary DI: 03700483602544
• Version / Model: INFLATION SYRINGE AND TUBING SET
• Catalog Number: 19183
• Company Name: MORIA SA
• Labeler DUNS: 275937506
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-29
• Public Version: 1
• Public Version Date: 2024-01-08
• Public Version Status: New
• Public Device Record Key: 7de73f5e-1c57-4f8e-9315-88c0481ab22c

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
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45358	Corneal resection holder, single-use	A device designed to hold donated corneal tissue so that it can be resected in preparation for transplantation. The device may be in the form of a pedestal, with retention and locking rings, upon which the donated cornea is placed and inflated with air, or some other material, to simulate the pressure of the anterior chamber of the eye for the procedure. This method allows resection from the epithelial side of the cornea. The device may also include tubing and clips, and inflation is typically achieved manually with a syringe. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03700483602551	GS1		10	In Commercial Distribution
Primary	03700483602544	GS1