RECELL C3RL01-B:US

GUDID 00851707004149

RECELL Autologous Cell Harvesting Device

AVITA MEDICAL AMERICAS, LLC

Autologous skin cell grafting kit

• Primary Device ID: 00851707004149
• NIH Device Record Key: 342a3555-a0fa-476d-9aba-492f5bf9f1f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RECELL
• Version Model Number: US 1920
• Catalog Number: C3RL01-B:US
• Company DUNS: 026723570
• Company Name: AVITA MEDICAL AMERICAS, LLC
• 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	00851707004149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP170122

FDA Product Code

• QCZ: Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator

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: 2018-11-26
• Device Publish Date: 2018-10-26

On-Brand Devices [RECELL]

• 00851707004149: RECELL Autologous Cell Harvesting Device
• 00851707004200: RECELL Autologous Cell Harvesting Device
• 00851707004262: RECELL Autologous Cell Harvesting Device