OMNI Surgical System (US) 1-102

GUDID 00858027006334

OMNI System for US in a single pack

SIGHT SCIENCES, INC.

Ophthalmic needle, single-use

• Primary Device ID: 00858027006334
• NIH Device Record Key: f923d797-44c8-45ca-819e-eef6590c675c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNI Surgical System (US)
• Version Model Number: FG 05757
• Catalog Number: 1-102
• 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	00858027006334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173332

FDA Product Code

• MRH: Pump, Infusion, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-04
• Device Publish Date: 2019-10-25

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