OMNI Surgical System (US)

Basic Information

• Brand Name: OMNI Surgical System (US)
• Primary DI: 00858027006334
• Version / Model: FG 05757
• Catalog Number: 1-102
• Company Name: Sight Sciences, Inc.
• Labeler DUNS: 962750381
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-25
• Public Version: 4
• Public Version Date: 2023-08-22
• Public Version Status: Update
• Public Device Record Key: f923d797-44c8-45ca-819e-eef6590c675c
• Distribution End Date: 2019-10-28

Device Description

OMNI System for US in a single pack

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: No
• 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
MRH	Pump, Infusion, Ophthalmic	General Hospital	880.5725	2
HMZ	Trabeculotome	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47610	Ophthalmic needle, single-use	A slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a single-use device.	No	Active
62437	Trabeculotome, single-use	A hand-held manual ophthalmic surgical instrument intended to be used to perform a trabeculotomy, via transluminal access through Schlemm's canal (sinus venosus sclerae) and piercing of the trabecular meshwork, to reduce intraocular pressure (IOP) for the prevention/treatment of glaucoma. It is made of metal and plastic materials, and is in the form of a handle with a thin, flexible, extendable tip at the distal end designed to be progressively inserted into the eye through a corneal incision. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858027006334	GS1

Premarket Submissions

Submission Number	Supplement Number
K173332	000