MEIBOMIAN GLAND EVALUATOR

Basic Information

• Brand Name: MEIBOMIAN GLAND EVALUATOR
• Primary DI: 00859623006018
• Version / Model: MGE-1001
• Catalog Number: 300001
• Company Name: TEARSCIENCE, INC.
• Labeler DUNS: 791626901
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-20
• Public Version: 5
• Public Version Date: 2024-01-09
• Public Version Status: Update
• Public Device Record Key: d90d8d4d-9eb5-46e6-b713-3b6191a6311c

Device Description

MEIBOMIAN GLAND EVALUATOR - US

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HOE	Caliper, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62775	Meibomian gland manual expressor/evaluator	A non-powered, hand-held manual ophthalmic instrument intended to be used to apply pressure to the lower eyelid to facilitate natural release and/or expression of meibomian gland secretions (meibum) for diagnostic evaluation during a routine eye examination and/or to treat dry eye syndrome. It is a small tool with a handle and a distal end of various configurations (e.g., shaft, paddle, roller, tweezers-like) designed to be gently pressed against the outer skin of the lower eyelid or to gently squeeze the lower eyelid. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859623006018	GS1

Customer Contacts

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