TRAB(TM)360 Trabeculotomy System

GUDID 00858027006112

US version of the TRAB360

SIGHT SCIENCES, INC.

Trabeculotome, single-use

• Primary Device ID: 00858027006112
• NIH Device Record Key: 0062e8fc-6537-45d5-ab20-bfb66f724b8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRAB(TM)360 Trabeculotomy System
• Version Model Number: FG 03706
• Company DUNS: 962750381
• Company Name: SIGHT SCIENCES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00858027006112 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-23

Devices Manufactured by SIGHT SCIENCES, INC.

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• 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