Diamatrix

Basic Information

• Brand Name: Diamatrix
• Primary DI: 00813059013002
• Version / Model: M 24125-1
• Catalog Number: M 24125-1
• Company Name: Diamatrix
• Labeler DUNS: 809555139
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-02
• Public Version: 1
• Public Version Date: 2020-07-10
• Public Version Status: New
• Public Device Record Key: 7b92e6f1-24e0-4e66-be82-2830701534c8

Device Description

Lu-Mendez Degree Gauge and Fixation Ring, Marked in 10 Degree Increments, Conical Micro-Teeth on Bottom of Ring, Stainless Steel.

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HMR	Marker, Ocular	Ophthalmic	886.4570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37896	Corneal marker, reusable	A manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long slender handle with a distal end having characteristics for producing specific markings. The device may have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and horizontal points for precision alignment. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813059013002	GS1