ML7070 (Minus 20)

Basic Information

• Brand Name: ML7070 (Minus 20)
• Primary DI: 00850724001568
• Version / Model: ML7070 (-20)
• Catalog Number: ML7070 (-20)
• Company Name: MED LOGICS INC
• Labeler DUNS: 075390489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-14
• Public Version: 1
• Public Version Date: 2020-08-24
• Public Version Status: New
• Public Device Record Key: 49acc89f-17a2-4329-a564-2c14244dbd82

Device Description

Sterile disposables microkeratome blade, for use on the Hansatome Microkeratome

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: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNO	Keratome, Ac-Powered	Ophthalmic	886.4370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44722	Keratome blade, single-use	A surgical cutting device with a very sharp edge that is designed to be mounted into a keratome and is used to shave tissue from sections of the cornea. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850724001565	GS1	Box	10	In Commercial Distribution
Primary	00850724001568	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K993225	000