Sterile Malleable Lame Bistoury Blade MJK BW064M - Delynov
The Lame malléable de bistouri stérile MJK BW064M 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.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the MJK BW064M malleable blade?
The MJK BW064M sterile malleable scalpel blade is a high-precision cutting instrument specifically developed by MJK Instruments AG. Unlike standard scalpel blades, this model features a controlled deformation capability, allowing the practitioner to bend the blade to adapt to the anatomical constraints of the oral cavity. This device is delivered in sterile packaging, ensuring optimal safety for each intervention. As a micro-blade, it is particularly suited for minimally invasive surgical techniques where fine soft tissue management is an absolute priority for post-operative healing.
What are the clinical indications for this periodontal surgery blade?
This malleable scalpel blade from the MJK brand is primarily indicated for soft tissue surgery. In clinical practice, it is used to perform intrasulcular incisions, releasing incisions, or connective tissue graft harvesting. Its ability to be modeled makes it indispensable for periodontal and implant surgery procedures requiring difficult access, such as maxillary molar sectors or mandibular lingual areas. It allows for a clean and precise cut, limiting tissue trauma during the creation of full-thickness or partial-thickness flaps.
What are the technical specifications of the MJK BW064M blade?
The MJK BW064M blade is distinguished by its technical reference n°64, often referred to as micro-blades in the surgical field. It is manufactured to offer an extremely sharp edge, essential for incisions without tissue compression. Its major characteristic lies in its malleability, offering flexibility that conventional blades do not possess. This medical device is classified as Class IIa, meeting strict safety and performance requirements. It is generally available in boxes of 10 units, with each blade individually wrapped to maintain its sterility until the moment of use in the operating room.
What are the contraindications for the use of this device?
According to the information provided by the manufacturer, there are no specific medical contraindications listed for the use of the MJK BW064M blade, other than those related to standard surgical protocols. However, the use of this device is strictly reserved for qualified healthcare professionals. It is imperative not to use the blade if the sterile packaging is damaged, in order to avoid any risk of cross-contamination. The practitioner must evaluate the relevance of the tool based on the patient's pathology and the area to be treated, while respecting the precautions for use related to sharp instruments.
What are the precautions for use for this sterile blade?
The MJK BW064M blade is an extremely sharp device that requires careful handling to avoid accidental injury. As a single-use device, it must under no circumstances be re-sterilized or reused, as this would not only compromise its sharpness but also increase infectious risks. After use, the blade must be disposed of in a sharps container compliant with hazardous healthcare waste (DASRI) management standards. The manufacturer recommends reading the instructions for use carefully before any handling to ensure implementation in accordance with safety requirements.
Who is the manufacturer and what standards are respected?
The MJK BW064M malleable blade is manufactured by MJK Instruments AG, a recognized manufacturer in the field of precision instrumentation. This medical device benefits from the CE0246 marking, certifying its compliance with current European regulations. It is classified as Class IIa according to medical device classification criteria. Production is carried out in collaboration with Susruta Instruments Pvt Ltd, ensuring a rigorous manufacturing process. Compliance with these international standards ensures dental surgeons and implantologists a reliable, sterile, and high-performance product for their daily oral surgery interventions.
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Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | MJK Professional Dental Instruments |
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