Techinal data sheet Albino Dias de Andrade S.A. non sterile swab in vacuum Non-invasive device, as mechanical barrier, for compression or for absorption of exudates in daily curative procedures of chronic wounds, minor burns or other injuries with skin damage. This dressing has several dimensions and different number of layers, to allow a better adaptation to the injured surface or to the surgical procedure. For this reason it should always be used in its final fold, and should never be unfolded. Although the residual risks founded are so low that they are negligible, in the case of an invasive medical device, there is always the probability, even insignificant, of undesirable side effects like allergies. However, there is no history of side effects with this product. Non-woven fabric composed of viscose and polyester of 30g/m2, with total size 20cmx20cm and folded 10cmx10cm, folded in 4 layers, presented in non-sterile form, packed in a vacuum system that reduces the development of aerobic bacteria to 99.9%. It is characterized by softness and poor abrasiveness. Latex and phthalates free. MD Class I according to Regulation (EU) 2017/745 of the European Parliament and Council. The target audience of this device is health professionals or people with relevant knowledge in the area, so given the intended use of the device, it can be used safely with-out instructions, so instruction sheets are not available with the device. This device is a single-use device and does not have reprocessing instructions. The risk associated to reprocessing of the product, is very high due the biological contamination of the patient, and to the impossibility of total elimination of biological material. Using disposable items eliminates the risk of patient-to--patient contamination because the item is discarded and not used anymore. The product biocompatibility is ensured by tests performed according ISO 10993, namely cytotoxicity, sensitization and irritation. worldwide producer of medical devices

Techinal data sheet Albino Dias de Andrade S.A. (eu-mdr^4 Physical-Chemical Characteristics Characteristics Meth°d Requirements Weight (g/m2) Tensile strength wet (daN): Extension at break (%): Extension at break wet (%): Absorption capacity (%): Sinking time (seg): pH: Water soluble substance (%): Ether soluble substance (%): Surface-active substances | Microbiologic Characteristics Aerobics Bacteria Yeasts and modulus | Biocompatibility Skin sensitization Skin irritation Cytotoxicity Does not cause skin sensitization EN ISO 10993 Does not cause skin irritation I Otras propriedades Reference...

Techinal data sheet Albino Dias de Andrade S.A. • Primary packaging – Polyethylene bag • The product is valid for 5 years after the date of manufac- • Secondary packaging – cardboard box ture. Medical device name Registered trademark Indication of medical device Product reference Primary package Expiration date Manufacturer name European Commission Manufacturer headquarters address CE marking Indication for single use Indication of the reprocessing prohibition Non-Sterile indication Medical device name Registered trademark Indication of medical device Secondary package Identification of the package...