CER FISS TNT ESTENS CM15X10M

TNT FIXING PATCH
STRETCHABLE NON STERILE

Disposable Medical Device

Class of belonging: the Legislative Decree 46/97 on Medical Devices classifies this product in class I for the purposes of CE marking.

Intended use: non-invasive device, to be used for fixing dressings, bandages, catheters, drainage tubes, probes, gauze with vaseline, cotton gauze on sensitive skin.

Characteristics: the non-woven mesh plaster roll is made with the use of ventilated, light and thin, extensible medical grade non-woven fabric. Permeable to air and water vapour, radiolucent, sterilizable and latex free. Coated with hypoallergenic polyacrylate adhesive. Equipped with silicone-coated protective paper pre-cut lengthwise, easily removable while keeping the dressing intact. Removable in an atraumatic way without releasing residues.

CHARACTERISTICS AND PROPERTIES silicone paper

Composition	Medical non-woven fabric: 70% viscose + 30% polyester
Color	natural white
Weight [g/m 2 ]	75±5
Adhesive
Composition	acrylic and hypoallergenic adhesive
Weight [g/m 2 ]	25 ±5
Steel tack for peeling [N/cm]	≥1
Longitudinal extensibility [%]	880±100
Permeability to water vapor [g/m 2 /24h]	3700 ±500
Air permeability [g/m 2 /24 h]	1250 ±100
protective card
Composition
Color	white background, blue centimeter grid

Reference Standards:
- complies with the standards of the Official Pharmacopoeia in force;
- compliant with EN ISO 13485:2012 Medical Devices - Quality management systems - Requirements for regulatory purposes;
- compliant with ISO 9001:2008 Quality management systems-Requirements standards;
- compliant with Directive 93/42/EEC relating to Medical Devices as amended by 2007/47/EEC, implemented with Legislative Decree 24 February 1997 n. 46 and subsequent amendments

Packaging: single in cardboard box which allows to preserve the content from any pollutants and to store the devices in an optimal way within the departments. The characteristics and performance are not altered during storage and transport, thanks to the packaging that allows storage. The rigid cardboard packaging is impact-resistant, sealed with adhesive tape, dust-tight and suitable for non-overlapping storage.

Labeling in Italian: labeling compliant with Directive 93/42/EEC on "Medical Devices", implemented with Legislative Decree no. 46 of 24 February 1997 and subsequent amendments and additions. The labeling is placed on the box and on the carton.

Box - primary packaging
- Product Description
- Product code
- N° of pieces contained
- Intended use
- Disposable (symbol)
- Measurements, dimensions, length
- CE marking
- Name and address of the manufacturer
- Batch, production date and expiration date
- Specific instructions for use
- EAN barcode