OMNI PLUS

GUDID 00858027006358

OMNI PLUS Surgical System

SIGHT SCIENCES, INC.

Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use

• Primary Device ID: 00858027006358
• NIH Device Record Key: 69eab465-93c5-4362-9aed-01cded0dc44a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNI PLUS
• Version Model Number: 1-104
• 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	00858027006358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201953

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: 2020-11-09
• Device Publish Date: 2020-10-30

Devices Manufactured by SIGHT SCIENCES, INC.

• 00858027006433 - OMNI Surgical System: 2023-10-25 OMNI Surgical System, 21 uL
• 00858027006389 - TearCare(R) Clearance Assistant PLUS: 2023-08-30 TearCare Clearance Assistant PLUS
• 00858027006280 - TearCare SmartLid: 2023-08-22 Eyelid heat therapy system applicator
• 00858027006266 - TearCare(R) Clearance Assistant - Sterile: 2023-08-04 Forceps - Sterile
• 00858027006525 - OMNI Surgical System: 2022-08-30 OMNI Surgical System: Ergo series of revisions
• 00858027006501 - Sion Surgical Instrument: 2022-08-09 The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument.
• 00858027006457 - TearCare System - TearCare SmartHub Kit: 2022-03-11 TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter
• 00858027006495 - TearCare System - TearCare SmartLids: 2022-03-11 Eyelid heat therapy system applicator