OMNI Surgical System (US) 1-100

GUDID 00858027006310

Omni System for US in a single pack

SIGHT SCIENCES, INC.

Trabeculotome, single-use

• Primary Device ID: 00858027006310
• NIH Device Record Key: 63b00054-9e61-46ea-8b9a-1ba268385fd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNI Surgical System (US)
• Version Model Number: FG 05600
• Catalog Number: 1-100
• Company DUNS: 962750381
• Company Name: SIGHT SCIENCES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858027006310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173332

FDA Product Code

• HMZ: Trabeculotome

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-03-16

On-Brand Devices [OMNI Surgical System (US)]

• 00858027006310: Omni System for US in a single pack
• 00858027006334: OMNI System for US in a single pack