Documents

Indications For Use (US & Canada)

The Puregraft 50 System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

The Puregraft 250 System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

The Puregraft 850 System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

Instructions For Use (US & Canada)

600-012-04-H IFU, Puregraft 50 System (Global)

600-013-06-A IFU, Puregraft 50 System (CAN-French)

600-013-01-C IFU, Puregraft 250 (US)

600-014-01-C IFU, Puregraft 850 (US)

Indications For Use (EU)
The Puregraft 50 System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for Autologous Fat Transfer (AFT) procedures.

The Puregraft 250 System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for Autologous Fat Transfer (AFT) procedures.

The Puregraft 850 System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for Autologous Fat Transfer (AFT) Procedures.

Instructions For Use (EU)

600-012-04-H IFU, Puregraft 50 System (Global)

600-013-02-D IFU, Puregraft 250 (INT)

600-014-02-D IFU, Puregraft 850 (INT)

Disclaimer

This product is certified as a medical device in the European Union under the Medical Device Directive 93/42/EEC by SGS CE1639, exclusively for the indication of autologous fat transfer. Other non-medical uses ascribed to this device such as aesthetic body contouring are not within the scope of CE certification, and users should be aware product performance and/or safety has not been evaluated by SGS for those purposes.

Hospital Value Added Committee (VAC) Pack (US & Canada)

Bimini Health Tech is aware of the challenges of introducing new products within a hospital product registry.  We have compiled information specifically to help address and facilitate discussions that hospital board review committees may require or conduct prior to approving Puregraft for purchase.

PG VAC Packet 500-052-01 REV. A