GENERAL INFORMATION |
7
LABELS
The device is manufactured in accordance to the Good Manufacturing Practices set forth by the
FDA, ISO Standards (International) and CE (Conformité Européenne or European Conformity)
standards and testing results per Article 9. The device is a Class I Shock Protection and a Class II
Medical device. Each of these governing agencies requires specific labeling. All required labels are
affixed per the relevant codes. Each label is pictured and described in this section. Additionally,
the placement of each label on the device is communicated.
The following diagram shows the compliance labels and their placement.
The large black background label is this primary label and is compliant to FDA and ISO standards;
the image captures the FDA code regulated classifications and International criteria. One of the (2)
identified pinch points is labeled below.
Summary of Contents for Z6
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