Gauze compresses 10x10cm 8-fold, 100 pieces

Product description and intended purpose

The gauze compresses are non-sterile packed, 8-ply compresses made of 17-thread gauze.They have a size of 10 cm x 10 cm and are available in a quantity of 100 pieces.The cut edges are turned inwards.These compresses are used for general first aid treatment of wounds, for wound cleaning, for wound covering and for absorbing blood and body fluids.They are intended for single use and must be sterilized using a validated procedure before use on open wounds.Suitable sterilization methods are moist heat according to DIN EN ISO 17665, radiation according to DIN EN ISO 11137 or ethylene oxide according to DIN EN ISO 11135.

Composition

The gauze compresses are made of cotton.

Contraindications

There are no known contraindications unless there is an allergy to cotton.

Normative and legal requirements

The gauze compresses are class I medical devices, rule 4 according to the MPG, Directive 93/42/EWG and MDR (EU) 2017/745.They meet the requirements of DIN EN 14079. According to the European standard EN ISO 10993-1 "Biological assessment of medical devices", gauze compresses are medical devices that come into contact with body surfaces (skin and mucous membrane) and are classified with contact duration A (less than 24 hours).The product does not contain any dangerous toxic substances according to REACH.It carries CE and DIN EN ISO 15223-1 and EN 1041 marking on all packaging levels.

Packaging

The primary packaging consists of a sterilizable paper bag.The secondary packaging is a cardboard box made of cellulose.

Storage

The gauze compresses should be stored dry and dust-free.

Instructions for use

Before use, the gauze pads must be sterilized.No prescription is required for this product.

More information

This leaflet was last revised in February 2018. Source: Information in the package insert.As of: 04/2020.