Sterile Micro Lame Bistoury Spoon MJK number 2 (SB002) - Delynov

What is the MJK sterile spoon micro-scalpel blade number 2 (SB002)?

The MJK sterile spoon micro-scalpel blade number 2, referenced under code SB002, is a precision instrument specifically designed for delicate surgical interventions. This medical device, manufactured by MJK Instruments AG, is distinguished by its spoon blade shape, optimized for procedures requiring great finesse. It is a sterile, single-use accessory, ensuring maximum safety during each surgical act. Its design allows practitioners to access restricted areas with increased efficiency while maintaining rigorous control during soft tissue manipulation.

What are the clinical indications for this MJK device?

The intended use for this MJK micro-blade is strictly surgical. It is primarily indicated for the incision of soft tissues during complex procedures. In oral and implant surgery, this type of blade is preferred for performing precise incisions where conventional scalpels might lack maneuverability. Its specific profile meets the requirements of dental surgeons and implantologists during the preparation of surgical sites or flap management. The clinical objective is to ensure a clean cut to promote optimal healing of the incised tissues.

What are the technical characteristics of the SB002 blade?

The MJK micro-blade SB002 is characterized by its extremely sharp edge, an essential property for minimizing tissue trauma during incision. As a Class IIa medical device, it meets strict manufacturing requirements to guarantee its performance in a sterile environment. Its structure is adapted for integration onto compatible micro-scalpel handles. The technical specifications of this number 2 model are designed to offer a balance between rigidity and cutting precision, allowing the healthcare professional to perform technical movements with great fluidity.

What are the contraindications and limitations of use?

Although specific contraindications are not detailed beyond the intended use for soft tissue incision, the use of this device is strictly reserved for qualified healthcare professionals. The micro-blade must not be used outside the surgical framework defined by the manufacturer Susruta Instruments Pvt Ltd. It is imperative not to use the product if the sterile packaging is damaged, in order to avoid any risk of cross-contamination. Compliance with aseptic protocols and standard surgical techniques is essential to prevent any intraoperative or postoperative complications.

What are the precautions for use for this extremely sharp equipment?

Due to its extremely sharp nature, handling the MJK SB002 micro-blade requires particular vigilance to avoid any accidental injury to the practitioner or nursing staff. It is strongly recommended to read the instructions for use carefully before any handling. As this device is sterile and single-use, it must under no circumstances be cleaned or resterilized after use. After the intervention, the blade must be disposed of in accordance with the protocols in force for sharps (DASRI), to ensure safety within the dental practice or clinic.

Who is the manufacturer and what standards are met by this product?

The spoon micro-scalpel blade is manufactured by MJK Instruments AG, with manufacturing ensured by Susruta Instruments Pvt Ltd, located in Ahmedabad, India. This medical device complies with current European regulations, as evidenced by its CE0246 marking. It is classified as Class IIa according to medical device classification criteria. Compliance with these standards guarantees that the product meets the safety and performance requirements defined for invasive surgical instruments. Traceability and sterility are at the heart of MJK's manufacturing processes to ensure the reliability of the equipment delivered to implantologists.

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