1 box of 20 sterile 0.9% sodium chloride solutions of 250ml - Physiological saline - Omnia - Delynov (32.E0002.00)
The 1 carton de 20 Solutions stérile de chlorure de sodium à 0.9% de 250ml - Serum physiologique - Omnia is a medical device manufactured by Omnia S.p.A. — Class I, CE marking CE25657.
- Compliance: Medical device Class I, CE marking CE25657.
- Manufacturer: Omnia S.p.A..
- Reference: 32.E0002.00.
- Reserved for healthcare professionals. Read instructions carefully before use.
fabricant :OMNIA S.R.L. IT - 43036 FIDENZA (PR) - VIA FRANCESCO DELNEVO 190 réservé aux professionnels de santé.Lire attentivement la notice avant utilisation.
What is the Omnia sterile sodium chloride solution?
The 0.9% sterile sodium chloride solution offered by Omnia, under reference 32.E0002.00, is an essential medical device for clinical environments. This product, commonly known as physiological saline, is packaged in cartons of 20 units, each bottle or container having a capacity of 250ml. Designed by the manufacturer Omnia S.p.A., this sodium solution is specifically developed to meet cleaning and irrigation needs during surgical procedures. Its sterile formulation guarantees optimal safety during use by healthcare professionals, ensuring the maintenance of a clean surgical field and tissue hydration during care protocols.
What are the clinical indications for this product?
This 0.9% sodium chloride solution is indicated for professional use within the framework of medical and surgical procedures. It is primarily used for wound irrigation, cleaning medical devices, and rinsing tissues during dental or oral surgery interventions. This Omnia product allows for the elimination of cellular and blood debris while respecting the isotonicity of body fluids. Its use is strictly reserved for qualified healthcare professionals who must follow current clinical protocols. Precise indications provided by the manufacturer OMNIA S.R.L. highlight its crucial role in maintaining asepsis during operative phases.
What are the technical characteristics of this solution?
Product 32.E0002.00 is characterized by a 0.9% concentration of sodium chloride, making it a sterile isotonic solution. The 20x250 ml packaging (20 containers of 250ml) allows for efficient stock management for practices performing dental or implant surgery. This device belongs to Class I according to current regulations. Sterility is a central element of its technical design, guaranteeing the absence of viable microorganisms at the time of opening. Technical specifications comply with the rigorous standards of the manufacturer Omnia S.p.A., located in Fidenza, Italy, ensuring compatibility with the requirements of modern operating theaters.
What are the contraindications for the use of this physiological saline?
Although 0.9% sodium chloride is a standard solution, its use must comply with the warnings of the manufacturer OMNIA S.R.L. It is imperative to read the instructions carefully before any use. Contraindications may include specific hypersensitivities or clinical situations where the intake of sodium or chloride is prohibited. This product must not be used if the container shows signs of deterioration or if the solution is no longer clear, as this would compromise its sterility. It is reminded that this device is exclusively reserved for healthcare professionals and must not be diverted from its intended use for clinical irrigation and cleaning.
What are the precautions for use for this medical device?
To guarantee the efficacy and safety of the Omnia sterile solution, several precautions must be observed. The product must be used immediately after opening to preserve its sterile character; any unused remaining solution must be disposed of in accordance with medical waste management protocols. Healthcare professionals must check the integrity of the packaging before use. It is essential to respect the storage conditions recommended by the manufacturer to maintain the physicochemical properties of the sodium chloride. Aseptic handling is mandatory when transferring the solution to the surgical field to avoid any cross-contamination during the intervention.
Who is the manufacturer and what standards are respected?
The sterile sodium chloride solution is manufactured by Omnia S.p.A. (OMNIA S.R.L.), headquartered in Fidenza, Italy. This medical device complies with European regulatory requirements and bears the CE25657 marking. Classified as a Class I device, it meets the safety and performance standards imposed by the Medical Device Regulation (MDR). The manufacturer ensures full traceability and rigorous quality control for each carton of 20 units of 250ml produced. Compliance with these standards guarantees dental surgeons and implantologists a reliable, secure product perfectly adapted to the requirements of contemporary oral surgery.
State of the art
Single-use sterile surgical kits significantly reduce intraoperative contamination.
Specifications
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