1 box of 20 sterile 0.9% sodium chloride solutions of 250ml - Physiological saline - Omnia - Delynov (32.E0002.00)

What is Omnia 0.9% sterile sodium chloride solution?

Omnia product 32.E0002.00 is a 0.9% sterile sodium chloride solution, commonly known as physiological saline. Packaged in boxes of 20 units of 250ml, this solution is specifically designed to meet sterility requirements in surgical environments. Manufactured by Omnia S.p.A., it is presented in a liquid, clear, and pyrogen-free form, offering optimal biological compatibility for tissues during operative phases. This 250ml format is particularly suitable for single use, thus guaranteeing the integrity of the sterile chain during each surgical act.

What are the clinical indications for this physiological saline?

In oral and implant surgery, this surgical irrigation solution is indicated for cleaning osteotomy sites and irrigating soft tissues. The use of sterile sodium chloride is essential for cooling drills during bone drilling, thus avoiding any thermal necrosis of the alveolar bone. It is also used for rinsing post-extraction sites and during guided bone regeneration surgeries. As a dental irrigation solution, it maintains optimal visibility of the operative field by safely evacuating blood and cellular debris.

What are the technical characteristics of this product (ref 32.E0002.00)?

This sterile sodium chloride irrigation solution is characterized by a precise concentration of 0.9% NaCl, corresponding to the osmolarity of human body fluids. The packaging in boxes of 20 bottles or bags of 250ml allows for efficient stock management for clinics practicing implantology regularly. The design of the container ensures easy connection to standard irrigation lines. This medical device is classified as Class I, meeting strict European safety standards for products intended for professional clinical use.

What are the contraindications for the use of this solution?

Although the raw MDR text does not specify particular clinical contraindications for this product, the use of this solution must be strictly reserved for external use and surgical irrigation. It must not be injected intravenously unless the packaging explicitly specifies it. As with any medical device, it is imperative to check the integrity of the packaging before use; a damaged container compromises the sterility of the solution. Practitioners must refer to the instructions for use for any specific warnings related to the handling of the Omnia product.

What are the precautions for use to maintain sterility?

To guarantee the effectiveness of the surgery physiological saline, the product must be stored according to the recommendations of the manufacturer Omnia S.p.A. Each 250ml unit is for single use; any remaining solution after a procedure must be systematically discarded to prevent risks of cross-contamination. Healthcare personnel must handle the bottle respecting strict asepsis protocols when connecting to irrigation systems. It is essential to read the instructions carefully before use and to ensure that the CE2565 marking is present, guaranteeing the compliance of the device with regulatory requirements.

Who is the manufacturer and what standards are respected?

The product is manufactured by Omnia S.p.A., located in Fidenza, Italy. This recognized manufacturer in the dental sector guarantees that this solution meets the requirements of Class I. The device bears the CE2565 marking, attesting to its compliance with European directives on medical devices. As a sterile dental sodium chloride solution, it undergoes rigorous controls to ensure its pyrogen-free nature and sterility. Traceability is ensured by the technical reference 32.E0002.00, allowing healthcare professionals to maintain precise tracking of their medical devices within the practice.

State of the art

Single-use sterile surgical kits significantly reduce intraoperative contamination.