Monitor 55 Inch

GUDID G465FG1800

4K Monitor 55 Inch

Smartsurgn Inc.

Endoscopic video image display unit

• Primary Device ID: G465FG1800
• NIH Device Record Key: 7abdb306-7999-4a68-9728-0cc67d0f11a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monitor 55 Inch
• Version Model Number: FG-18
• Company DUNS: 115617378
• Company Name: Smartsurgn 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
HIBCC	G465FG1800 [Primary]

FDA Product Code

• OWN: Confocal Optical Imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-21
• Device Publish Date: 2025-03-13

Devices Manufactured by Smartsurgn Inc.

• G465100300 - AirSurgN Insufflator: 2025-04-30 AirSurgN Insufflator
• G465FG1800 - Monitor 55 Inch: 2025-03-214K Monitor 55 Inch
• G465FG1800 - Monitor 55 Inch: 2025-03-21 4K Monitor 55 Inch
• G465FG13240 - Light Cable: 2024-07-25 Schott Fiber Optic Light Cable
• G465FG11220 - OptIcSurgN: 2024-02-07 OptIcRSurgN 10mm ICG Laparoscope 0°
• G465FG11230 - OptIcSurgN: 2024-02-07 OptIcRSurgN 10mm ICG Laparoscope 30°
• E30000019 - EyeRSurgN: 2023-11-28 EyeRSurgN Camera System
• G465FG13140 - View4SurgN: 2023-10-30 32" 4K Monitor
• G465100100 - EyeRSurgN: 2023-10-24 4K 4-Chip Camera Console