Needle holder 0.022 inch tip x 0.025 inch beak - Hu-Friedy - Delynov
The Pince<=0.022 inch x 0.025 inch Tip Back - 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 Hu-Friedy Tip Back plier?
The Hu-Friedy Tip Back plier is a specialized manual instrument used primarily in orthodontics and during certain phases of corrective surgeries. Manufactured by Hu-Friedy Mfg. Co., LLC, this plier is designed to handle wires with dimensions up to 0.022 inch x 0.025 inch. Its structure is optimized for distal bending, offering a firm grip and rigorous control during archwire shaping. As a Class I device, it meets the basic regulatory requirements for non-invasive reusable instruments intended for qualified healthcare professionals.
What are the clinical indications for this device?
This device is indicated for procedures requiring a wire bending plier with a specific tip back function. In clinical practice, it is used to bend the distal end of an orthodontic archwire to prevent it from sliding out of the molar tubes or injuring the patient's soft tissues. It is used by dental surgeons and orthodontists during the placement or adjustment of multi-bracket appliances. The intended use, as defined by the manufacturer Hu-Friedy, is strictly reserved for healthcare professionals trained in distal bending techniques.
What are the technical characteristics of the Tip Back plier?
The plier features technical characteristics adapted to rectangular or square section wires up to a maximum capacity of 0.022 inch x 0.025 inch. Its design allows for a clean distal bend without weakening the metallic structure of the wire. Hu-Friedy instrumentation is recognized for its adjustment precision at the level of the jaws, ensuring that the bend is made exactly at the desired location. The head geometry is designed to access the posterior areas of the oral cavity, thus facilitating work on molar segments.
What are the contraindications for the use of this instrument?
According to the information provided by Hu-Friedy Mfg. Co., LLC, the use of this instrument is reserved exclusively for healthcare professionals. Contraindications include use on wires whose dimensions exceed the specified maximum capacity of 0.022 inch x 0.025 inch, which could damage the plier jaws or cause wire breakage. The instrument should also not be used for tasks other than bending orthodontic wires, such as cutting thick wires or manipulating bone structures, for which it is not designed.
What are the maintenance precautions for this non-resorbable plier?
As a Class I reusable surgical instrument, the Tip Back plier must be subject to a strict sterilization protocol between each patient. Although the specific material is not detailed here, Hu-Friedy standards generally involve cleaning, disinfection, and steam sterilization (autoclave) processes in accordance with the manufacturer's technical instructions. It is imperative to read the instructions carefully before use to verify compatible sterilization cycles and ensure the longevity of the instrument while guaranteeing the aseptic safety of interventions.
Who is the manufacturer and what standards are respected?
The official manufacturer of this medical device is Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This product is classified as a Class I medical device. Compliance with manufacturing standards by Hu-Friedy ensures practitioners a reliable instrument for orthodontic tip back bending. As a Class I device, it is subject to the conformity assessment procedures applicable to this category of instruments. Users must systematically refer to the instructions for use and the manufacturer's warnings to guarantee use in accordance with regulatory requirements.
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Specifications
| Manufacturer | Hu-Friedy |
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