OptIcSurgN

GUDID G465FG11220

OptIcRSurgN 10mm ICG Laparoscope 0°

Smartsurgn Inc.

Rigid optical laparoscope

• Primary Device ID: G465FG11220
• NIH Device Record Key: 2f6e0188-0ecd-46b1-86e8-a55bc2946454
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptIcSurgN
• Version Model Number: FG1122
• Company DUNS: 115617378
• Company Name: Smartsurgn 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G465FG11220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213943

FDA Product Code

• OWN: Confocal Optical Imaging

Sterilization

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

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

[G465FG11220]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-07
• Device Publish Date: 2024-01-30

On-Brand Devices [OptIcSurgN]

• G465FG11230: OptIcRSurgN 10mm ICG Laparoscope 30°
• G465FG11220: OptIcRSurgN 10mm ICG Laparoscope 0°