Disposable Kits, Sterile and Non-Sterile

GUDID 00850470007418

RESTORATION ROBOTICS, INC.

Hair extraction punch

• Primary Device ID: 00850470007418
• NIH Device Record Key: 989ca22e-241c-4448-ad97-496f08cf9a6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Kits, Sterile and Non-Sterile
• Version Model Number: 18G 2 Prong
• 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: true
• Serial Number: false
• 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	00850470007418 [Primary]

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: 2018-04-09
• Device Publish Date: 2018-03-07

Devices Manufactured by RESTORATION ROBOTICS, INC.

• 00850470007524 - ARTAS iX: 2018-12-13
• 00850470007531 - ARTAS iX: 2018-12-13
• 00850470007562 - Disposable Kit, Sterile and Non Sterile, iX: 2018-12-13
• 00850470007579 - Disposable Kit, Sterile and Non Sterile, iX: 2018-12-13
• 00850470007623 - Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX: 2018-12-13
• 00850470007630 - Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX: 2018-12-13
• 00850470007364 - Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile: 2018-07-06
• 00850470007371 - Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile: 2018-07-06