X1 Benex Screwdriver for Insert (BE001 055) - Meisinger - Hager & Meisinger GmbH (47BE001230055)
The x1 tournevis benex pour insert (be001 055) - meisinger - hager & meisinger gmbh (47be001230055) is a medical device manufactured by Hager & Meisinger GmbH — Class IIa, CE marking CE0044.
- Compliance: Medical device Class IIa, CE marking CE0044.
- Manufacturer: Hager & Meisinger GmbH.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Benex screwdriver for insert (be001 055) Meisinger?
The Benex screwdriver for insert, referenced under code be001 055 by the manufacturer Hager & Meisinger GmbH, is a precision manual instrument. Developed specifically for the GBR (Guided Bone Regeneration) category and extraction procedures, this Class IIa medical device is an essential complementary tool for the Benex system. Its structure is designed to meet the requirements of oral surgery, allowing for secure handling of inserts. As a Meisinger product, it benefits from German manufacturing rigor, guaranteeing strict compliance with European health standards for invasive surgical devices for temporary use.
What are the clinical indications for this oral surgery screwdriver?
The use of this screwdriver for insert is indicated in the fields of dentistry, implantology, and maxillary surgery. It is primarily used during dental extraction techniques requiring the use of the Benex system for root avulsion. According to the recommendations of the manufacturer Hager & Meisinger GmbH, the use of this device assumes adequate expertise and experience in diagnosis, preoperative planning, and surgical techniques. The practitioner decides, under their sole responsibility, on the use of the device on a case-by-case basis, depending on the particular clinical indication encountered during bone treatment or general surgery.
What are the technical characteristics of this Meisinger device?
This Benex screwdriver (reference 47be001230055) is a hand instrument that must be handled with protective gloves in accordance with safety directives. As a CE0044 certified medical device, it complies with Class IIa requirements. Technical specifications emphasize that for hand instruments in this range, care should be taken to ensure gentle and flexible handling to preserve the integrity of the device and ensure optimal performance during oral surgery interventions. Non-compliant use can lead to premature wear of the device, compromising the safety of patients and users.
What are the contraindications for the use of this instrument?
The major contraindications lie in use by unqualified personnel. According to Hager & Meisinger GmbH, these devices may only be used by dentists, doctors, or specialists who have acquired solid training and experience. In-depth knowledge in dental implantology or maxillary surgery is required. Furthermore, any use not compliant with the intended use constitutes a contraindication, as it can induce risks for the user and the patient. The practitioner must refer to the manufacturer's specifications and the catalog to ensure that the intended application corresponds to the specific development of the instrument.
What are the precautions for use and handling?
Handling this screwdriver for insert requires the systematic wearing of protective gloves. To guarantee the longevity of the instrument and operative safety, the manufacturer Meisinger recommends gentle and flexible use. A suction device is necessary during certain dry-use phases to maintain a clear and secure operative field. It is also imperative to follow the continuous training sessions offered by the manufacturer to master the possible applications. Any serious incident related to the use of the device must be immediately notified to Hager & Meisinger GmbH as well as to the competent authority of the Member State concerned.
Who is the manufacturer and what standards are respected?
The device is manufactured by Hager & Meisinger GmbH, located in Neuss, Germany. This recognized manufacturer complies with strict regulatory standards, as evidenced by the CE0044 marking affixed to the product. The Benex screwdriver is classified as a Class IIa medical device according to current regulations. Compliance with European requirements ensures that the instrument has been developed for specific use in surgical and medical environments. For any additional information on standards or training related to Meisinger devices, professionals can consult the manufacturer's official resources or refer to the instructions for use provided.
State of the art
Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.
Specifications
| Manufacturer | Meisinger |
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