RECELL GO

GUDID 00851707004279

RECELL GO Autologous Cell Harvesting Device (Processing Device)

AVITA MEDICAL AMERICAS, LLC

Autologous skin cell grafting kit

• Primary Device ID: 00851707004279
• NIH Device Record Key: 38f9f1dd-595c-42ce-ba7a-c816d64cef5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RECELL GO
• Version Model Number: AVRL0104
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	00851707004279 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-07
• Device Publish Date: 2024-05-30

On-Brand Devices [RECELL GO]

• 00851707004286: RECELL GO Autologous Cell Harvesting Device (Preparation Kit)
• 00851707004279: RECELL GO Autologous Cell Harvesting Device (Processing Device)