Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile

GUDID 00850470007388

RESTORATION ROBOTICS, INC.

Hair extraction punch

• Primary Device ID: 00850470007388
• NIH Device Record Key: b02db57f-be42-4b40-ac42-02c714fb48e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile
• Version Model Number: 19G 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00850470007388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103428

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-07

On-Brand Devices [Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile]

• 00850470007395: 19G 4 Prong
• 00850470007388: 19G 2 Prong
• 00850470007371: 18G 4 Prong
• 00850470007364: 18G 2 Prong