EyeRSurgN

GUDID G465100100

4K 4-Chip Camera Console

Smartsurgn Inc.

Endoscopic video image processing unit

• Primary Device ID: G465100100
• NIH Device Record Key: fe9823cc-8ae2-4fc4-ad79-53497275a153
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EyeRSurgN
• Version Model Number: 10010
• 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: 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	G465100100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213943

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: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [EyeRSurgN]

• G465100100: 4K 4-Chip Camera Console
• E30000019: EyeRSurgN Camera System