RECELL AVRL0102

GUDID 00851707004262

RECELL Autologous Cell Harvesting Device

AVITA MEDICAL AMERICAS, LLC

Autologous skin cell grafting kit

• Primary Device ID: 00851707004262
• NIH Device Record Key: 2528c2c7-8f09-47a4-aa3e-36bba2621ec5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RECELL
• Version Model Number: US 480
• Catalog Number: AVRL0102
• 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	00851707004262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP220799

FDA Product Code

• QWY: Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, 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: 2023-07-13
• Device Publish Date: 2023-07-05

On-Brand Devices [RECELL]

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