1 box of 15 sterile 0.9% sodium chloride solutions of 500ml - physiological saline - Omnia - Delynov (32.E0001.00)
Optimize surgical irrigation with Omnia sterile solution
Ensure effective cooling of your rotary instruments during oral surgery procedures with this ready-to-use sodium chloride solution.
- Composition: 0.9% Sodium chloride (NaCl).
- Use: Non-injectable sterile solution for instrument cooling.
- Packaging: Box of 15 bags of 500 ml.
- Safety: Class I medical device, CE14590 marking.
The 1 carton de 15 Solutions stérile de chlorure de sodium à 0,9% de 500 ml - serum physiologique - Omnia is a medical device manufactured by Omnia S.p.A. — Class I, CE marking CE14590.
- Compliance: Medical device Class I, CE marking CE14590.
- Manufacturer: Omnia S.p.A..
- Intended use: Single-use sterile surgical kit for oral, implant, and periodontal procedures; ensures regulatory traceability (UDI).
- Reference: 32.E0001.00.
- 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 0.9% sodium chloride sterile solution?
The Omnia 0.9% sodium chloride (NaCl) sterile solution is a ready-to-use medical device designed for surgical irrigation. Presented in 500 ml bags, this physiological saline solution is specifically formulated to meet the requirements of clinical environments. It is packaged in a carton of 15 units for optimal stock management in dental practices. This non-injectable product ensures essential purity during invasive procedures, thus guaranteeing a working environment that complies with hospital hygiene standards.
What are the clinical indications in surgery?
In oral surgery, this solution is primarily indicated to ensure effective cooling of rotary instruments. Continuous irrigation prevents thermal heating of bone tissue and adjacent structures during drilling or cutting. It is recommended for maintaining visibility of the operative field by removing debris and blood. Its use is strictly reserved for healthcare professionals for interventions requiring constant refrigeration of surgical devices to preserve cell viability.
What are the technical characteristics of the Omnia solution?
The Omnia solution (reference 32.E0001.00) is characterized by a precise composition of 0.9% sodium chloride. The technical packaging includes a carton of 15 bags, each bag containing a volume of 500 ml. It is a sterile and non-injectable solution. The bag design allows for easy connection to standard irrigation systems used in dental surgery. These specifications guarantee optimal compatibility with cooling protocols for rotary instruments during implant or periodontal procedures.
What are the contraindications for use?
This sodium chloride solution is strictly non-injectable. It must under no circumstances be administered intravenously or parenterally. Its use is exclusively limited to external irrigation and the cooling of instruments. It is imperative not to use the product if the packaging or the bag shows signs of damage, as sterility would no longer be guaranteed. Professionals must refer to the instructions for any specific contraindication related to the patient's clinical condition or known hypersensitivities to the components.
How is handling performed and what precautions should be taken?
Handling must be performed by a qualified healthcare professional. Before any use, it is necessary to read the instructions carefully. The solution must be used immediately after opening the bag to maintain its sterility. When installing on the surgical motor, ensure that aseptic rules are followed so as not to contaminate the irrigation circuit. Particular attention must be paid to the integrity of the container before use. After the intervention, any unused solution residue must be disposed of in accordance with medical waste disposal protocols.
Who is the manufacturer and which standards are respected?
The official manufacturer of this device is Omnia S.p.A. (or Omnia S.R.L.), located in Fidenza, Italy. This product is a Class I medical device, benefiting from the CE14590 (or CE14590/2 according to registers) marking. Compliance with these European standards attests to the product's conformity with safety and performance requirements for surgical irrigation. Traceability is ensured by the reference code 32.E0001.00, guaranteeing practitioners reliable and rigorously controlled equipment for their daily practice.
State of the art
Single-use sterile surgical kits significantly reduce the risk of intraoperative contamination. Regulatory traceability (UDI) remains a key concern.
Specifications
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