Implant Card/Patient ID

Warnings, precautions or measures to be taken by the patient or a healthcare professional in relation to mutual interference with reasonably foreseeable external influences, medical tests or environmental conditions:
The medical device is sterile and intended for human implantation. It is composed of collagen of animal origin completely similar to human collagen: in stable contact with the patient's healthy tissues, the device is repopulated by the cells and transformed into the patient's own tissue in approximately 6 months with a regenerative process. Beyond these, there are no particular considerations or precautions that the patient or healthcare professionals must take in relation to the implantation of this device.

Information on the expected useful life of the device and any necessary follow-up:
The device, transforming into the patient's tissue, requires follow-up only for the duration of the regenerative process. Subsequently, visits or tests may be necessary to follow up on any primary pathology or to check other devices that may have been implanted together with this one, for which please refer to the respective manufacturers.

Any other information aimed at ensuring safe use of the device by the patient, including the information referred to in Annex I, point 23.4, letter u): "in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients may be exposed;”
The device is composed of collagen entirely derived from equine pericardium and its use is contraindicated in patients allergic or hypersensitive to materials of equine origin. The device, once implanted, is identifiable at the implant site only for the time necessary for its transformation into the patient's own tissue through the natural replacement/turnover of collagen (approximately 6 months).