Handpiece, ML7

Basic Information

• Brand Name: Handpiece, ML7
• Primary DI: 00850724001803
• Version / Model: 1400ML7
• Catalog Number: 1400ML7
• Company Name: MED LOGICS INC
• Labeler DUNS: 075390489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-27
• Public Version: 1
• Public Version Date: 2020-09-04
• Public Version Status: New
• Public Device Record Key: 53caa655-06d7-4e45-b8bb-eb7f9f4b84bc

Device Description

Handpiece for use with the ML7 Microkeratome

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
62703	Microkeratome	An electrically-powered ophthalmic surgical instrument intended to be used to create a corneal pocket for the insertion of a corneal implant or to create a flap to prepare the cornea for laser vision correction. It typically consists of a suction ring, an applanator for flattening of the cornea and a mounted blade to create a corneal pocket or a flap. This device is not intended to be used to cut or shave tissue sections from the cornea.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850724001803	GS1

Customer Contacts

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