1 box of 15 sterile 0.9% sodium chloride solutions of 500ml - physiological saline - Omnia - Delynov (32.E0001.00)

What is the Omnia sterile sodium chloride solution?

The 0.9% sterile sodium chloride solution marketed by Omnia is a physiological saline solution packaged in 500 ml bottles. This product, referenced under code 32.E0001.00, comes in a box containing 15 units. It is an isotonic NaCl (sodium chloride) solution designed to meet sterility requirements in surgical environments. This medical device is classified as Class I according to current regulations. Omnia S.p.A., a recognized manufacturer in the field of surgical devices, guarantees the compliance of this solution for rigorous professional use.

What are the clinical indications for this physiological saline solution?

In oral surgery and implantology, the use of a sterile 0.9% sodium chloride surgery solution is fundamental. It is primarily indicated for the irrigation of the operative field to ensure optimal visibility and to prevent thermal heating of bone tissues during implant drilling. This physiological saline also serves for cleaning surgical wounds and rinsing soft tissues. Although specific MDR indications are not detailed in the provided documentation, the use of this NaCl solution is a clinical standard for maintaining asepsis and hydration of intervention sites.

What are the technical characteristics of this Omnia product?

This Omnia product (reference 32.E0001.00) is characterized by a 0.9% concentration of sodium chloride, making it an isotonic solution compatible with biological fluids. The packaging in a box of 15 bottles of 500 ml is adapted to the logistical needs of practices regularly performing surgery. The solution is sterile and non-injectable, in accordance with safety standards for irrigation. Manufacturing is carried out by Omnia S.p.A. in Italy, respecting strict quality standards for Class I devices.

What are the contraindications for the use of this solution?

The provided regulatory text does not mention specific medical contraindications for this 0.9% sodium chloride solution. However, as with any medical device, it is imperative to check the integrity of the bottle before use to guarantee the sterility of the solution. This product is exclusively reserved for healthcare professionals. It is necessary to systematically refer to the instructions for use provided by the manufacturer Omnia before any handling to ensure the suitability of the product for the planned surgical procedure.

What are the precautions for use for this medical device?

The use of this sterile sodium chloride solution requires strict compliance with aseptic protocols. The practitioner must ensure that the bottle has not been opened or damaged before the intervention. As a Class I device, its use is intended for external irrigation or cleaning and not for injection. It is recommended to read the instructions carefully before use. Storage must be carried out according to the recommendations of the manufacturer Omnia S.p.A. to preserve the physico-chemical properties of the 0.9% NaCl.

Who is the manufacturer and what standards are respected?

This solution is manufactured by Omnia S.p.A., located in Fidenza, Italy. The product complies with European requirements and bears the CE1459 marking. It is listed as a Class I medical device. The manufacturer Omnia is a reference in the dental and surgical sector, ensuring rigorous traceability and production quality. Compliance with these standards guarantees dental surgeons and implantologists the use of a reliable product for their daily interventions requiring sterile physiological saline.

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Single-use sterile surgical kits significantly reduce intraoperative contamination.