ARTAS iX FP-47000

GUDID 00850470007531

RESTORATION ROBOTICS, INC.

Robotic surgical system

• Primary Device ID: 00850470007531
• NIH Device Record Key: a6c0a3c2-4706-4e66-b5eb-d0936296d743
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTAS iX
• Version Model Number: Chair
• Catalog Number: FP-47000
• Company DUNS: 627212587
• Company Name: RESTORATION ROBOTICS, 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
GS1	00850470007531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173358

FDA Product Code

• ONA: Computer Assisted Hair Harvesting System

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: 2018-12-13
• Device Publish Date: 2018-11-12

On-Brand Devices [ARTAS iX]

• 00850470007531: Chair
• 00850470007524: System