OMNI Surgical System 1-106

GUDID 00858027006433

OMNI Surgical System, 21 uL

Sight Sciences, Inc.

Ophthalmic needle, single-use

• Primary Device ID: 00858027006433
• NIH Device Record Key: c2bb3d8e-fded-453a-a997-d3b5e32cbaa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNI Surgical System
• Version Model Number: FG 07758
• Catalog Number: 1-106
• 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	00858027006433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232214

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: 2023-10-25
• Device Publish Date: 2023-10-17

On-Brand Devices [OMNI Surgical System]

• 00858027006525: OMNI Surgical System: Ergo series of revisions
• 00858027006433: OMNI Surgical System, 21 uL