ReCell Autologous Cell Harvesting Device - Autologous skin cell grafting kit

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Disponibil de la:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Clasă:

Class III

Produs de:

Avita Medical Americas LLC 28159 Avenue Stanford Suite 220, Valencia, CA, 91355 United States Of America

Zonă Terapeutică:

58417 - Autologous skin cell grafting kit

Indicații terapeutice:

A single-use, stand-alone, battery-operated, autologous cell harvesting device containing enzymatic and delivery solutions, sterile surgical instruments, and actuators. Enables thin split-thickness skin samples to be processed to produce a cell population for immediate delivery onto a prepared wound surface. The cell suspension contains a mixed population of cells obtained from the disaggregation of the skin sample inc melanocytes is important for restoring natural pigmentation to the recipient. ReCell is intended to be used to disaggregate cells from split-thickness skin samples and to collect these cells for reintroduction to the patient. These cells can be used as determined by a physician for: ? Treatment of partial-thickness tissue defects, including burns ? Reconstruction of scars to improve surface colour and texture ? Reconstructive surgery for epidermal defect (e.g., hypo-pigmentation, stable vitiligo)

Statutul autorizaţiei:

A

Data de autorizare:

2020-07-03