Saw blades are supplied in the new sterile envelope packaging concept. The blades are packed in individual blister packs. Each blister pack contains a set of labels comprising the main label and 4 patient labels. To ensure safe transport to the patient, the blisters are packed in a box made of a sturdy material along with the instructions for use. The packaging unit is 5 pieces. One set of instructions is enclosed with each box. Selected articles will be supplied in sterile multi-blister packs instead of the envelope packaging concept.
The EPC is a double sterile barrier system consisting of an inner and an outer blister encased in a cardboard box. The new main label is placed on the cardboard box and shows information in multiple languages. A secondary label and 4 patient-labels are placed on the sterile blister. Multilingual instructions for use are enclosed with each packaging unit.
MIS Burs/Cutters are packed in multi-blister packs. Each blister pack contains a set of labels comprising the main label and 4 patient labels. To ensure safe transport to the patient, the blisters are packed in a box made of a sturdy material along with the instructions for use. The packaging unit is 1 piece. One set of instructions is enclosed with each box.
We introduce a new label with information in multiple languages. With the new label and the revised multilingual instructions for use, all requirements imposed by the MDR with regards to labeling are met.
