MSI Precision Specialty Instruments

Basic Information

• Brand Name: MSI Precision Specialty Instruments
• Primary DI: 00194613050979
• Version / Model: 15-3628AS
• Company Name: Med Saver, Inc.
• Labeler DUNS: 556623486
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-15
• Public Version: 2
• Public Version Date: 2025-07-30
• Public Version Status: Update
• Public Device Record Key: 0ee596dd-b5e2-4737-be6e-c04c8a0f0438

Device Description

Nagahara Phaco Chopper, For Use In LH, Angled 45 Degrees, Flat Interior Cutting Edge, 10mm Bend To Tip, 1.5mm 60 Degrees Long Cutting Edge, Round Knurled Handle, Overall Length 4-1/2" (114mm)

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
HND	Spatula, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13120	Ophthalmic surgical probe, reusable	A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00194613050979	GS1

Customer Contacts

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