LSO QuickSet

Basic Information

• Brand Name: LSO QuickSet
• Primary DI: 00871321002215
• Version / Model: LQ2000
• Catalog Number: N/A
• Company Name: Labtician Ophthalmics, Inc
• Labeler DUNS: 248911026
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-26
• Public Version: 6
• Public Version Date: 2021-01-27
• Public Version Status: Update
• Public Device Record Key: cd108d8f-7799-446c-a2b4-f94e40cfe8de

Device Description

A device adapter that connects VFI machines to a syringe, providing pressurized air in assisting clinicians in depressing syringe.

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: 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
IQG	Adaptor, Holder, Syringe	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47240	Ophthalmic irrigation/infusion/aspiration tubing, single-use	A length of flexible, noninvasive tube intended to connect an ophthalmic cannula to an external device(s) [e.g., pump, bottles] for infusion, irrigation and/or aspiration (suction) during an ophthalmic procedure [e.g., tamponade, glaucoma treatment]. It is made of polymer material(s), may incorporate single- or double-lumen and may be provided in rolls from which required lengths are cut, or in predetermined lengths. It may be provided with simple connectors; however, it does not include other associated items (e.g., clamp, spike) [i.e., not a tubing set]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00871321002215	GS1

Customer Contacts

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