THORNTON TWO RAY MERIDIAN MARKER

Basic Information

• Brand Name: THORNTON TWO RAY MERIDIAN MARKER
• Primary DI: 00192896097117
• Version / Model: T12-9100-2
• Catalog Number: T12-9100-2
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-09
• Public Version: 3
• Public Version Date: 2019-10-03
• Public Version Status: Update
• Public Device Record Key: 94316cfd-17d6-47bb-b25b-ba5558a802f8

Device Description

THORNTON TWO RAY MERIDIAN MARKER SINGLE ENDED ROUND HANDLE TITANIUM

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: Yes
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMQ	Marker, Sclera	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	00192896097117	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	4	Inch