Lasik Markers

Basic Information

• Brand Name: Lasik Markers
• Primary DI: 08175700110020
• Version / Model: AS3-602
• Catalog Number: AS3-602
• Company Name: AURORA SURGICAL, LLC
• Labeler DUNS: 968368832
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-23
• Public Version: 2
• Public Version Date: 2024-01-17
• Public Version Status: Update
• Public Device Record Key: 01d3c9b9-6bcd-4f4a-a2e5-93779966ac0d

Device Description

Lasik Marker, with 3.5mm and 4.0mm Intersecting Circles, Titanium (Gulani Style)

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HLF	Device, Measuring, Lens Radius, Ophthalmic	Ophthalmic	886.1430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63521	Ophthalmic angular gauge, reusable	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 reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08175700110020	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]