ML Eyespear ML 100

GUDID 40850724001504

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

MED LOGICS INC

Ophthalmic sponge

• Primary Device ID: 40850724001504
• NIH Device Record Key: 5b139dec-fa12-484f-a3f0-c6d523d84113
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ML Eyespear
• Version Model Number: ML 100
• Catalog Number: ML 100
• Company DUNS: 075390489
• Company Name: MED LOGICS INC
• Device Count: 200
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-651-2962
• Email: justin.ross@mlogics.com
• Phone: 1-800-651-2962
• Email: justin.ross@mlogics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850724001506 [Unit of Use]
GS1	40850724001504 [Primary]
GS1	50850724001501 [Package]; Package: Bag [5000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002279

FDA Product Code

• HOZ: Sponge, Ophthalmic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[40850724001504]

Radiation Sterilization

[40850724001504]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

Devices Manufactured by MED LOGICS INC

• 10850724001107 - Vacuum Tubing: 2020-09-07 Disposable Microkeratome Vacuum Tubing
• 00850724001902 - ML7 Eye Marker: 2020-09-07 Eye Marker use to mark the cornea to orientate the ML7 Vacuum Ring
• 00850011743997 - Wrench, Helical Drive, ML7: 2020-09-04 Wrench use to adjust helical screw on the ML7 Vacuum Rings
• 10850724001206 - Vacuum Tubing: 2020-09-04 Disposable Tubing for use with the ML7 Microkeratome
• 00850724001681 - ML7 Microkeratome: 2020-09-04 Console for use with the ML7 microkeratome
• 00850724001780 - Footswitch, ML7: 2020-09-04 Footswitch for use with the ML7 microkeratome
• 00850724001803 - Handpiece, ML7: 2020-09-04 Handpiece for use with the ML7 Microkeratome
• 00850724001810 - Sterilization Tray, ML7: 2020-09-04 Sterilization tray for use with the ML7 microkeratome