Malosa Medical

Basic Information

• Brand Name: Malosa Medical
• Primary DI: 35055186208340
• Version / Model: MMSU1405S
• Catalog Number: MMSU1405S
• 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: 4
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: c4c5463e-de27-43ff-a761-12db71eb7a78

Device Description

Schocket Double-Ended Scleral Depressor

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
HNX	Depressor, Orbital	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64317	Orbital depressor, single-use	A hand-held ophthalmic surgical instrument designed for extra-orbital displacement of the sclera to facilitate examination/treatment of the surrounding area in the orbital cavity during eye surgery; it may be designed to be used with a light source (not included). Sometimes referred to as a scleral depressor, it is often a double-ended device of various sizes and shapes (e.g., flat, curved, spoon-shaped, or fenestrated) with the working end(s) slightly angled to improve organ/tissue manipulation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	05055186208349	GS1
Primary	35055186208340	GS1