Sterile bistoury blade MJK number 2 (BW002) - Delynov
Product features
The Lame de bistouri stérile MJK numéro 2 is a medical device manufactured by MJK Instruments AG — Class IIa, CE marking CE0246.
- Compliance: Medical device Class IIa, CE marking CE0246.
- Manufacturer: MJK Instruments AG.
- Intended use: Surgical consumable designed for oral, dental, and implant surgery procedures by qualified healthcare professionals.
- Reference: BW002.
- Reserved for healthcare professionals. Read instructions carefully before use.
Fabricant : Susruta Instruments Pvt Ltd GIDC Vatva Ahmedabad – 382445 – India - Usage prévu : Chirurgie - Incision des tissus mous - Lire attentivement la notice. Avertissement et précautions : Extrêmement tranchant – Dispositif médical - Réservé aux professionnels de santé.
What is the MJK sterile scalpel blade number 2 (BW002)?
The MJK sterile scalpel blade number 2, referenced under code BW002 at Delynov, is a precision instrument designed for surgical interventions. This medical device, developed under the MJK brand name, is an essential sharp tool for practitioners requiring optimal cutting quality during their operative acts. As a sterile consumable, this blade is specifically developed to meet the needs of clinical environments where asepsis is paramount. It fits perfectly into the arsenal of healthcare professionals for performing clean incisions. Its design by MJK Instruments AG guarantees a rigorous manufacturing standard, thus ensuring constant reliability during each use in the clinic or operating room.
What are the clinical indications for this MJK device?
The intended use for the MJK scalpel blade number 2 (BW002) concerns the field of surgery exclusively. It is specifically indicated for the incision of soft tissues, a fundamental step in many surgical procedures, particularly in oral, dental, and implant surgery. This device allows the surgeon to access operative sites with great precision. Its sharpness is optimized to minimize tissue trauma during the opening of flaps or the performance of excisions. It is imperative that the use of this equipment be reserved for qualified healthcare professionals trained in surgical incision techniques, in order to guarantee patient safety and the effectiveness of the clinical intervention in accordance with the recommendations of the manufacturer Susruta Instruments Pvt Ltd.
What are the technical characteristics of reference BW002?
The MJK scalpel blade number 2 is distinguished by technical characteristics focused on cutting performance and safety. Identified by technical code BW002, it is qualified by the manufacturer as being extremely sharp, which requires handling with extreme caution by healthcare personnel. This medical device is delivered sterile, ready for use for immediate surgical intervention. Although the exact material composition is not specified in the technical documentation provided, its design meets the strict requirements of Class IIa. This classification highlights its suitability for short-term invasive surgical acts. Each blade is designed to fit corresponding standard scalpel handles, ensuring perfect stability during soft tissue incision.
What are the contraindications and precautions for use?
The contraindications and precautions related to the MJK scalpel blade number 2 (BW002) are centered on operative safety. This device is exclusively reserved for healthcare professionals. A major precaution lies in the extremely sharp nature of the blade, requiring increased vigilance during mounting on the handle and during the surgical act to avoid any accidental injury. It is essential to read the attached instructions for use carefully before any handling. As with any sterile sharp instrument, its use is prohibited if the packaging is damaged, in order to guarantee the maintenance of asepsis. Furthermore, its use must be strictly limited to the soft tissue incision for which it was designed, thus avoiding any misuse that could compromise the integrity of the blade or patient safety.
What are the precautions related to handling a non-resorbable device?
Although the MJK scalpel blade number 2 is not an implantable device like a suture, it belongs to the category of non-resorbable surgical consumables that require strict post-operative precautions. After its use for soft tissue incision, the blade must be immediately disposed of in a sharps container compliant with biological safety standards. No attempt should ever be made to reuse or re-sterilize this device, as it is single-use. Handling must be performed with surgical gloves and a rigorous aseptic technique. Compliance with these disposal protocols is crucial to prevent the risks of cross-contamination and blood exposure accidents within the dental office or hospital structure.
Who is the manufacturer and what standards are met by this product?
The MJK sterile scalpel blade number 2 is manufactured by Susruta Instruments Pvt Ltd, located in Ahmedabad, India, on behalf of MJK Instruments AG. This medical device strictly complies with current European regulations, as evidenced by its CE0246 marking. It is classified as Class IIa according to medical device classification criteria, which attests to its level of safety and performance for surgical interventions. Compliance with these standards guarantees practitioners that the product meets essential health and safety requirements. Traceability and manufacturing quality are ensured by the official manufacturer, allowing dental surgeons and implantologists to use MJK products with full confidence for their soft tissue incision procedures.
State of the art
Surgical medical consumables play a decisive role in operative safety and tissue regeneration quality.
Specifications
| Manufacturer | MJK Professional Dental Instruments |
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