StrataXRT Description

StrataXRT is a semi-occlusive, self-drying and transparent gel. (See Table 1.)

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Specific Regulations Outline: Medicinal Products: The components of StrataXRT do not incorporate or administer medicinal products.
Human Blood Derivatives: The components of StrataXRT do not incorporate any human blood derivatives.
Animal Tissues: The components of StrataXRT are not manufactured utilizing animal tissues.
Software: The components of StrataXRT do not incorporate any software.
Personal Protective Equipment and Machineries: StrataXRT do not fall under the definition of machinery in directive 2006/42/EC or the personal protective equipment directive 89/686/EEC.
Biocompatibility: In accordance with ISO 10993-1:2009, StrataXRT is categorized as surface device, non-invasive medical devices, that are in contact with breached or compromised surface for permanent exposure. Please see SPA-TF-SX-302 Biocompatibility.
The Biocompatibility reports outlines details concerning biocompatibility data: (See Table 2.)

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Based upon the long-term clinical history and results of biocompatibility testing in accordance with the applicable parts of ISO 10993, StrataXRT is considered to be biocompatible with respect to the indication.
Sterilization: StrataXRT is sterile until opened.