1.2mm Square Screwdriver - Short - Titamed (IT0127) - delynov
The tournevis carré 1.2mm - court - titamed is a medical device manufactured by Titamed BV — Class I, CE marking CE0482.
- Compliance: Medical device Class I, CE marking CE0482.
- Manufacturer: Titamed BV.
- Reference: IT0127.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the 1.2mm square screwdriver - short - titamed (IT0127) - delynov?
The Titamed brand 1.2mm square screwdriver short, referenced under code IT0127, is a specific manual instrument intended for oral and maxillofacial surgery operating theaters. This 1.2 square screwdriver is distinguished by its short shaft, optimized for procedures where the working space is limited. Designed by the manufacturer Titamed BV, this tool is a Class I device essential for handling osteosynthesis screws or membrane fixation screws. Its robust structure allows for a firm grip by the practitioner, ensuring controlled force transmission during screwing or unscrewing in craniofacial bone structures.
What are the clinical indications?
According to data from the manufacturer Titamed BV, this surgery square screwdriver is exclusively intended for use during cranio- and maxillofacial surgeries. In clinical practice, it is used by dental surgeons and implantologists for the fixation of osteosynthesis material, particularly within the framework of Guided Bone Regeneration (GBR) protocols. This implantology square screwdriver is particularly indicated for stabilizing 1.2mm fixation screws in maxillary areas. Its use is strictly reserved for healthcare professionals trained in these specific surgical techniques, thus guaranteeing the safety and efficacy of the procedure for the patient.
What are the technical characteristics?
The Titamed IT0127 screwdriver presents precise technical specifications to meet the requirements of bone surgery. It features a 1.2mm square socket perfectly calibrated to fit the corresponding screw heads, limiting the risk of slipping or damaging the material. Its short implant screwdriver configuration is a major asset for posterior access or patients with reduced mouth opening. As a Class I medical device, it meets European quality standards, identified by the CE0482 marking. Although the exact composition is not specified, this type of titanium surgery screwdriver is designed to withstand the sterilization cycles required in hospital or office environments.
What are the contraindications for use?
The information provided by the manufacturer Titamed BV does not list specific medical contraindications related to the use of this instrument, beyond its intended use for cranio- and maxillofacial surgeries. However, as with any surgical instrument, its use is contraindicated outside the professional healthcare setting. It is imperative to read the instructions carefully before any handling. The practitioner must evaluate the patient's clinical condition and ensure that the device is compatible with the osteosynthesis material used. Any use not in accordance with the manufacturer's instructions could compromise the integrity of the instrument or the success of the surgical act.
What are the precautions for use and maintenance?
This Class I medical device requires particular attention regarding its maintenance. As a reusable instrument intended for craniofacial surgery, it must imperatively be cleaned, disinfected, and sterilized according to current protocols before each intervention. The manufacturer Titamed BV emphasizes the importance of reading the instructions carefully to respect the recommended maintenance cycles. Precautions for use include checking the integrity of the 1.2mm square socket before each use to avoid any mechanical play during screwing. This titanium surgery screwdriver must be handled with care to preserve its dimensional precision and functional longevity within the surgical arsenal.
Who is the manufacturer and what standards are respected?
The 1.2mm square screwdriver short (IT0127) is manufactured by Titamed BV, whose headquarters are located in Kontich, Belgium. This recognized manufacturer in the field of osteosynthesis guarantees the compliance of its instruments with European regulatory requirements. The product benefits from the CE0482 marking, certifying its compliance with safety and performance standards for medical devices. Classified as Class I, this screwdriver meets strict manufacturing criteria for manual surgical instruments. Titamed thus ensures dental and maxillofacial surgeons a reliable, traceable tool that complies with MDR directives for safe use during complex bone reconstruction procedures.
State of the art
Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.
Specifications
| Manufacturer | Titamed |
| Tags | |
|---|---|
| Tags | |