Surgical Needle Holder Backey No. 5046 Tungsten Carbide Fine 18cm - Hu-Friedy - Delynov
The Porte-aiguille De Backey #5046 carb. Tungstène fine 18cm - Hu-Friedy is a medical device manufactured by Hu-Friedy Mfg. Co., LLC.
- Compliance: Medical device Class I.
- Manufacturer: Hu-Friedy Mfg. Co., LLC.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the De Backey Hu-Friedy needle holder?
The De Backey #5046 needle holder from the brand Hu-Friedy is a high-precision surgical instrument specifically designed for holding suture needles. This model is distinguished by its fine structure and the integration of tungsten carbide jaws, a material recognized for its extreme hardness and its ability to maintain a firm grip without slipping. With a length of 18cm, this instrument allows the surgeon to access difficult areas of the oral cavity while maintaining optimal control. Manufactured by Hu-Friedy Mfg. Co., LLC, this Class I device meets the quality requirements of demanding practitioners in oral and implant surgery.
What are the clinical indications?
This tungsten carbide needle holder is indicated for all oral surgery procedures requiring precise soft tissue suturing. It is particularly used in periodontology for connective tissue grafts, in implantology for flap closure after implant placement, or during guided bone regeneration surgeries. Its fine design allows for the manipulation of small needles without damaging them, thus facilitating the performance of closely spaced sutures or tension-relieving sutures. The use of this device is strictly reserved for healthcare professionals trained in surgical techniques.
What are the technical characteristics?
The de bakey #5046 needle holder presents technical specificities adapted to micro-surgeries. Its main characteristic lies in its tungsten carbide inserts welded onto the jaws, offering a textured gripping surface that limits needle rotation during trans-mucosal passage. With a total length of 18cm, it offers a balanced lever arm for the practitioner. The thinness of its tips allows for increased visibility of the operative field, a major asset during interventions under optical magnification. This device is classified as a Class I instrument according to current regulations for medical devices.
What are the contraindications for use?
According to information provided by the manufacturer Hu-Friedy Mfg. Co., LLC, there are no specific medical contraindications listed for the use of this instrument, other than those related to standard surgical protocols. However, the use of this tungsten carbide needle holder is exclusively reserved for qualified healthcare professionals. It is imperative not to use the instrument for tasks for which it is not intended, such as manipulating thick metal wires or non-surgical materials, which could damage the tungsten carbide inserts or distort the alignment of the jaws.
What are the maintenance precautions for this non-resorbable device?
As a reusable surgical instrument made of steel and tungsten carbide, it must undergo a complete cycle of cleaning, disinfection, and sterilization before each use. Practitioners must pay particular attention to cleaning the textured jaws to remove any organic residue. Although tungsten carbide is extremely durable, sudden thermal shocks and prolonged exposure to corrosive solutions that could alter the bond between the insert and the instrument body should be avoided. It is recommended to read the Hu-Friedy manufacturer's instructions carefully before any commissioning to guarantee the longevity of the device.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 in the USA. This de bakey needle holder is a Class I medical device, which means it meets the safety and performance standards defined for reusable manual surgical instruments. Hu-Friedy is a recognized manufacturer in the dental sector for the quality of its alloys and the precision of its instruments. Healthcare professionals must refer to the manufacturer's instructions and warnings provided to ensure use in compliance with the regulatory requirements of the medical sector.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Hu-Friedy |
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