Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX FP-102777

GUDID 00850470007623

RESTORATION ROBOTICS, INC.

Hair extraction punch

• Primary Device ID: 00850470007623
• NIH Device Record Key: 61a7d413-248f-480d-b7f5-2597dd4e38d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX
• Version Model Number: 18G
• Catalog Number: FP-102777
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850470007623 [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: true

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 [Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX]

• 00850470007630: 19G
• 00850470007623: 18G