Malosa Medical

Basic Information

• Brand Name: Malosa Medical
• Primary DI: 35055186223299
• Version / Model: MMSU1297S
• Catalog Number: MMSU1297S
• Company Name: Beaver-Visitec International, Inc.
• Labeler DUNS: 001406024
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2022-02-19
• Public Version: 1
• Public Version Date: 2022-02-28
• Public Version Status: New
• Public Device Record Key: d415d040-a9f1-4c38-9b1d-ba13117b6794

Device Description

Reinstein Lenticule Separator

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59037	Ocular hook/spatula/manipulator, single-use	A hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation/implantation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	05055186223298	GS1
Primary	35055186223299	GS1

Customer Contacts

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