RECELL GO Preparation Kit (RPK) - Autologous skin cell grafting kit

Intended purpose

The RECELL GO Preparation Kit (RPK) consists of the following: • RECELL GO Processing Cartridge (RPC): The RECELL GO Cartridge is a sterile, single-use component of the RECELL GO Preparation Kit, which consists of additional components intended to be used for preparing the RECELL Spray-On Skin™ Cells. • RECELL GO Accessories: o RECELL Enzyme: The Enzyme is intended to provide enzymatic break-down of the extra- cellular matrix of skin sample to prepare cell suspension. o Buffer Solution: The Buffer solution is intended to be used as a carrier medium for the cell suspension (temporarily support cell viability). o Sterile water: The sterile water is intended to reconstitute the Enzyme. o Nozzles: The Spray Nozzles attach to the filled syringe and are intended to provide optimal delivery of the cell suspension over the treatment area. • RECELL GO Procedure Pack A: o Blunt Fill Needle: The Blunt Fill Needle is intended to draw up fluids from the RECELL Preparation Kit (RPK) component vials and transfer the fluid to the RECELL Processing Cartridge (RPC). The needle is also intended to draw up processed cells from the RPC and transfer the fluid or filtered cell suspension into the delivery syringe. o 10ml Disposable Syringe: The Syringe is intended to transfer the sterile water to reconstitute the Enzyme, transfer the Enzyme and buffer solution to the RPC, and deliver the final cell suspension to the patient. • RECELL GO Procedure Pack B: o Guarded Disposable Scalpel: The scalpel is intended to cut skin samples into pieces prior to placing in the RECELL GO Cartridge. o 10ml Disposable Syringe: The Syringe is intended to transfer the sterile water to reconstitute the Enzyme, transfer the Enzyme and buffer solution to the RPC, and deliver the final cell suspension to the patient.

Functional description

Used to disaggregate cells from a patient’s split-thickness skin sample and to collect these cells for autologous application to a prepared wound bed.