ML7040 (Minus 20) ML7040 (-20)

GUDID 10850724001046

Sterile Disposable microkeratome blade, for use on the Alcon SKBM Microkeratome

MED LOGICS INC

Keratome blade, single-use

• Primary Device ID: 10850724001046
• NIH Device Record Key: 6cf6a332-57e6-4c92-a9d4-1a38ae1fc7b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ML7040 (Minus 20)
• Version Model Number: ML7040 (-20)
• Catalog Number: ML7040 (-20)
• Company DUNS: 075390489
• Company Name: MED LOGICS INC
• Device Count: 1
• 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: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com
• Phone: 9495823891
• Email: justin.ross@mlogics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850724001049 [Primary]
GS1	10850724001046 [Package]; Contains: 00850724001049; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002515

FDA Product Code

• HNO: Keratome, Ac-Powered

Sterilization

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

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

[10850724001046]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-24
• Device Publish Date: 2020-08-14

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