MSI Precision Specialty Instruments

Basic Information

• Brand Name: MSI Precision Specialty Instruments
• Primary DI: 00194613106256
• Version / Model: 15-3805TAS
• Company Name: Med Saver, Inc.
• Labeler DUNS: 556623486
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-01
• Public Version: 1
• Public Version Date: 2025-08-11
• Public Version Status: New
• Public Device Record Key: 085509b3-5598-45c0-b958-e4b24ef2152f

Device Description

Toric Intra-Op Axis Marker II Degreega, Titanium, Two 2mm Marking Blades, Cutouts On Two 180 Degrees Positions For Easy Alignment, Markings Every 10 Degrees, Mounted At 90 Degrees Position, Round Handle

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: 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

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	00194613106256	GS1

Customer Contacts

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