ReCell Autologous Cell Harvesting Device - Autologous skin cell grafting kit

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Disponibbli minn:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Klassi:

Class III

Manifatturat minn:

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

Żona terapewtika:

58417 - Autologous skin cell grafting kit

Indikazzjonijiet terapewtiċi:

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)

L-istatus ta 'awtorizzazzjoni:

A

Data ta 'l-awtorizzazzjoni:

2020-07-03