X1 Safescraper Micross - Meta (4049) - Delynov

What is the Safescraper Micross - Meta (4049)?

The Safescraper Micross, manufactured by Meta Technologies S.R.L., is a sterile medical device specifically designed for harvesting autologous bone. This bone scraper allows surgeons to collect living bone tissue directly from the patient for grafting applications. Marketed under the Meta brand, this compact model facilitates access to narrow donor sites. It is presented as a ready-to-use autologous bone collector, ensuring simplified handling during oral surgery interventions. This device is delivered in sterile packaging (EtO) and has a specific technical reference under code 4049 for precise identification in the clinical inventory.

What are the clinical indications for the Micross?

The Safescraper Micross from the Meta brand is indicated for the harvesting and release of autologous bone during regenerative procedures. Its use is strictly reserved for surgeons specialized in dentistry operating in oral surgery. It is particularly useful for obtaining high-quality bone chips intended to fill bone defects or to increase the volume of the alveolar ridge before implant placement. This manual bone harvester is an effective solution for bone harvesting directly at intra-oral sites, thus allowing the use of the patient's own tissue, considered the gold standard in terms of biocompatibility and osteogenic potential.

What are the technical characteristics of this device?

This Class IIa medical device is distinguished by its integrated cutting mechanism designed for bone harvesting. The Safescraper Micross incorporates precision blades allowing for the harvesting of bone chips while temporarily storing them in an internal reservoir before their release at the recipient site. The design allows for efficient cutting without excessive pressure, preserving the vitality of the bone cells. It is a disposable instrument, delivered sterile, ensuring the absence of initial contamination. The manufacturer Meta Technologies S.R.L. has provided a secure opening of the blister via a specific "invitation," ensuring that asepsis is maintained until the moment of use by the practitioner.

What are the contraindications for the use of the Safescraper Micross?

The use of this device is contraindicated in cases of inappropriate hygiene that could lead to the transmission of infectious diseases or the failure of bone regeneration. The surgeon must imperatively evaluate the patient's suitability for bone grafting operations before any intervention. It is strictly forbidden to clean, resterilize, or reuse this instrument. Reuse would compromise surgical success due to blade wear, leading to a loss of cutting capacity, and would increase the risks of healthcare-associated infections or cross-contamination. Furthermore, the product must not be used if the sterile packaging is damaged or has been unintentionally opened before the surgical act.

What are the precautions for use and handling?

To ensure patient safety and the effectiveness of the graft, the surgeon must follow strict sterility procedures, including wearing sterile gloves when handling the Safescraper Micross. Before use, it is crucial to check the integrity of the blister. Any device with compromised packaging must be discarded and replaced with a new compliant product. The practitioner must establish an appropriate surgical sequence and take all necessary precautions to prevent complications related to the bone graft. As a single-use device, it must be discarded after the procedure, as its mechanical properties and sterility are no longer guaranteed after initial clinical contact.

Who is the manufacturer and what standards are met?

The Safescraper Micross is manufactured by Meta Technologies S.R.L., a company located in Reggio Emilia, Italy. This medical device is certified compliant with European regulatory requirements with CE0123 marking. It belongs to Class IIa according to the classification of medical devices. Sterilization is performed using ethylene oxide (EtO), a standard method guaranteeing a high level of microbiological safety for surgical instruments. As a recognized manufacturer, Meta ensures the traceability and compliance of this manual bone harvester, meeting the needs of implant and periodontal surgery professionals for their autologous bone requirements.

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