Sion Surgical Instrument

Basic Information

• Brand Name: Sion Surgical Instrument
• Primary DI: 00858027006501
• Version / Model: FG 08255
• Catalog Number: 1-107
• Company Name: Sight Sciences, Inc.
• Labeler DUNS: 962750381
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-01
• Public Version: 2
• Public Version Date: 2023-08-22
• Public Version Status: Update
• Public Device Record Key: d6cb0d0c-d3e6-4984-b50c-a0f379bee993

Device Description

The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument.

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: 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
HMZ	Trabeculotome	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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	00858027006501	GS1