TheraTears STERILID AM 2OZ SPRY 24

Basic Information

• Brand Name: TheraTears STERILID AM 2OZ SPRY 24
• Primary DI: 10058790005603
• Version / Model: 58790000560
• Company Name: Medtech Products Inc.
• Labeler DUNS: 060272465
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-07
• Public Version: 1
• Public Version Date: 2023-11-15
• Public Version Status: New
• Public Device Record Key: 9c0616fe-6589-4ecc-81c9-bd3298813354

Device Description

TheraTears STERILID AM 2OZ SPRY 24

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58837	Eyelid solution	A fluid material intended to be applied to the eyelids for various therapeutic ocular applications that typically include provision of supplemental lipids on the eyelid margin to stabilize the natural tear film lipid layer in the treatment of tear film deficiencies (e.g., dry eye syndrome), or to clean the eyelid or eyelid margin in the treatment of blepharitis and/or meibomian gland dysfunction. It is typically a liposomal (e.g., phospholipid) suspension or a saline solution, and is intended for use in the home or healthcare facility (single dose or multidose). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10058790005603	GS1		24	In Commercial Distribution
Primary	10058790005603	GS1

Customer Contacts

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