TEARSCIENCE ACTIVATOR CLEAR

Basic Information

• Brand Name: TEARSCIENCE ACTIVATOR CLEAR
• Primary DI: 00810051250022
• Version / Model: LFD-2100
• Catalog Number: 0803-5001
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Labeler DUNS: 010130626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-18
• Public Version: 1
• Public Version Date: 2021-10-26
• Public Version Status: New
• Public Device Record Key: e83bb39e-8ee0-4a75-bab7-0091f5f33a40

Device Description

TS ACTIVATOR CLEAR, BOX OF 1, US

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
58218	Eyelid thermal pulsation system applicator	An ophthalmic device designed to apply heat and pressure (intermittent pressure massage) to the outer eyelid surface for treatment of lid margin disease (LMD), meibomian gland dysfunction (MGD) and/or evaporative dry eye. It consists of two small plates, one positioned under the eyelid, and the other with heating/pulsing elements applied to the outside of the eyelid, and is used with a reusable control unit (not included). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810051250029	GS1	Box	1	In Commercial Distribution
Primary	00810051250022	GS1

Customer Contacts

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