Sterile Scalpel Blade MJK Number 4 (BW004) - Delynov
The Lame de bistouri stérile MJK numéro 4 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.
- Reference: BW004.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the MJK sterile scalpel blade number 4?
The MJK sterile scalpel blade number 4, referenced under code BW004 by Delynov, is a single-use cutting instrument intended for surgery. Manufactured by MJK Instruments AG, this micro-surgery blade is sterile-packaged to guarantee optimal safety during invasive procedures. It belongs to the surgical consumables (CONSO) category and is distinguished by its specific design adapted for size 4 handle supports, allowing precise handling for cutaneous or mucosal incisions.
What are the clinical indications for this device?
In accordance with data from the manufacturer Susruta Instruments Pvt Ltd, the intended use for this medical device is surgery, and more specifically soft tissue incision. In clinical practice, this sterile scalpel blade is used by dental surgeons and implantologists to create surgical access, perform releasing incisions, or prepare the operative site before implant placement or bone grafting. It allows for clean penetration into gingival or mucosal tissues, thus facilitating the practitioner's work during the initial phases of the procedure.
What are the technical characteristics of reference BW004?
Technical reference BW004 corresponds to a size number 4 sterile scalpel blade. This device is an extremely sharp instrument, an essential characteristic highlighted by the manufacturer to ensure a clean cut and limit mechanical trauma to the incision edges. As a Class IIa medical device, it meets strict safety and performance requirements. Its compatibility with standard size 4 scalpel handles makes it a versatile tool for oral surgery technical trays.
What are the contraindications for the use of this blade?
The source regulatory text does not specify any particular medical contraindications related to the composition or specific patient pathologies. However, the use of this sterile scalpel blade must be strictly limited to soft tissue incision, in accordance with its intended use. Its use on hard tissues or non-biological materials could damage the cutting edge and compromise the safety of the procedure. Like any sharp instrument, inappropriate handling constitutes a risk of injury to the operator or the patient.
What are the precautions for use and handling?
As the MJK blade is an extremely sharp device, it must be handled with extreme vigilance by healthcare professionals. It is a single-use sterile medical device; any reuse is prohibited to avoid risks of cross-contamination and loss of cutting power. After use, the blade must be disposed of in a sharps container compliant with biological safety standards. It is imperative to carefully read the instructions provided by MJK Instruments AG before any use to comply with safety protocols.
Who is the manufacturer and what standards are met?
The sterile scalpel blade number 4 is manufactured by MJK Instruments AG (Susruta Instruments Pvt Ltd). This medical device is certified Class IIa, guaranteeing its compliance with health and safety requirements. It bears the CE0246 marking, attesting to its evaluation by a notified body. The traceability and manufacturing quality of the MJK brand ensure dental surgeons reliable equipment for their daily procedures. Compliance with these European standards is an essential guarantee of safety for invasive devices used in a sterile environment.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | MJK Professional Dental Instruments |
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