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RECELL Autologous Cell Harvesting Device

PMA: BP170122 
Tradename: RECELL Autologous Cell Harvesting Device
Manufacturer: AVITA Medical Americas, Inc.
Indication:

  • The RECELL Autologous Cell Harvesting Device is indicated for the treatment of thermal burn wounds and full-thickness skin defects.
  • The RECELL Device is used by an appropriately licensed and trained healthcare professional at the patient’s point of care to prepare autologous Spray-On Skin Cells for direct application to acute partial-thickness thermal burn wounds in patients 18 years of age and older, or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients and full-thickness skin defects after traumatic avulsion (e.g., degloving) or surgical excision (e.g., necrotizing soft tissue infection) or resection (e.g., skin cancer) in patients 15 years of age and older.

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