ML Eyespear

Basic Information

• Brand Name: ML Eyespear
• Primary DI: 40850724001504
• Version / Model: ML 100
• Catalog Number: ML 100
• Company Name: MED LOGICS INC
• Labeler DUNS: 075390489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5b139dec-fa12-484f-a3f0-c6d523d84113

Device Description

Ophthalmic Sponge. The CleanTouch PVA Eye Spears are sterile, single-use devices designed to absorb excess fluids on the human eye.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOZ	Sponge, Ophthalmic	Ophthalmic	886.4790	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13704	Ophthalmic sponge	A device made of absorbent material, e.g., gauze, cotton or cellulose, intended to be used to absorb excess fluid produced by the eye during microsurgical procedures and ophthalmic surgery such as cataract surgery and laser assisted in situ keratomileusis (LASIK) procedures. Some types can be used as an eyelid and lash guard and are typically shaped for use in conjunction with an eye speculum. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	40850724001504	GS1
Unit of Use	00850724001506	GS1
Package	50850724001501	GS1	Bag	5000	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K002279	000