Tixel i HP

Basic Information

• Brand Name: Tixel i HP
• Primary DI: 07290117524084
• Version / Model: TiPH0001
• Company Name: NOVOXEL LTD
• Labeler DUNS: 600275858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-06
• Public Version: 1
• Public Version Date: 2026-04-14
• Public Version Status: New
• Public Device Record Key: 757232f9-d24e-46ae-8b7d-6e40baa56320

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
ORZ	Eyelid Thermal Pulsation System	Ophthalmic	886.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67438	Eyelid thermal pulsation system applicator, reusable	A hand-held component of an eyelid thermal pulsation system designed to apply pulsed heat and pressure to the outer eyelid surface for treatment of lid margin disease (LMD), meibomian gland dysfunction (MGD) and/or evaporative dry eye. It incorporates heating/pulsing elements applied to the outside of the eyelid and is designed for use with a dedicated control unit (not included). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290117524084	GS1