Surgical incision field 65x45 cm

Incision field designed to precisely delimit the anatomical part of the patient on which the surgery is going to be performed and protect it from possible contamination.

Composition:
- Breathable polyurethane.
- Hypoallergenic and biocompatible acrylic adhesive.
- Latex free.
- DEHP free.

Dimensions: 65 x 45 cm.

Sterilization: The product is supplied STERILE with Ethylene Oxide - not re-sterilizable.

Individually packaged.

Shelf life of 59 months.

Certificates:
- CE mark
- Compliance with regulation 93/42 EEC. Class IIa medical device EN ISO 13485:2016
- Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007
- Legislative Decree n. 46 of 24 February 1997 "Implementation of the
- Directive 93/42/EEC on medical devices".
- Legislative Decree n. 37 of 25 January 2010 'Implementation of the
- Directive 2007/47/EC
- UNI EN ISO 10993-1: Biological evaluation of medical devices - Evaluation and testing within a risk management process
- UNI EN ISO 10993-5: Biological evaluation of medical devices - In vitro cytotoxicity tests
- UNI EN ISO 10993-10: Biological evaluation of medical devices - Skin irritation and sensitization tests
- UNI EN ISO 11135: Sterilization of health care products - Ethylene oxide.
- UNI EN ISO 13795: Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment.

*Store in a place protected from direct sunlight, cool and dry, in an odor-free environment and away from heat sources.