Sterile Flexible Intubating Stylet

A Sterile Flexible Intubating Stylet is a single-use medical instrument designed to assist with the insertion of endotracheal tubes (ETTs) during tracheal intubation procedures. Crafted from a flexible yet shape-retaining core (typically medical-grade aluminum or stainless steel) encased in a smooth, biocompatible silicone or PVC sheath, it provides structural support to the soft ETT, enabling clinicians to navigate the airway with precision and control. Sterilized and ready for immediate use, it is an essential tool in operating rooms, emergency departments, ICUs, and pre-hospital care settings, streamlining intubation for patients of all ages.

The stylet's flexible core can be manually shaped to match the anatomical curvature of the oropharynx and trachea-such as a gentle "hockey stick" bend-to facilitate easy passage through the vocal cords without trauma to airway tissues. The smooth, non-stick outer sheath minimizes friction between the stylet and ETT, ensuring the tube glides smoothly during insertion and can be easily removed once the ETT is secured. Its length is customizable to fit adult, pediatric, and infant ETT sizes, with a distal tip that is rounded and atraumatic to prevent mucosal damage or perforation. The proximal end features a secure grip or luer lock to prevent accidental dislodgement during the procedure. Each unit is individually sterilized via EO gas, and undergoes rigorous quality testing including flexibility verification, shape retention assessment, and biocompatibility evaluation, complying with ISO 13485, CE, and NMPA standards for safe and efficient intubation.

Product Properties

 

 

1. Shape-Retaining Flexibility: Core can be manually bent to match airway anatomy and maintains shape during intubation, simplifying navigation through vocal cords.
2. Atraumatic Design: Rounded distal tip and smooth outer sheath minimize friction and prevent damage to pharyngeal and tracheal mucosa.Atraumatic Design: Rounded distal tip and smooth outer sheath minimize friction and prevent damage to pharyngeal and tracheal mucosa.
3. Size Customization: Length and diameter options match all standard endotracheal tube sizes for adult, pediatric, and infant patients.
4. Sterile & Ready-to-Use: Individual EO-sterilized packaging eliminates the need for pre-procedure sterilization, saving critical time in emergencies.
5. Depth Markings: Proximal cm markings enable clinicians to control insertion depth accurately and avoid over-advancement of the ETT.
6. Easy Removal: Smooth sheath ensures the stylet slides out effortlessly once the ETT is positioned and secured.

Application

 

 

Operating Room Anesthesia: Standard tool for elective intubation during general anesthesia for surgical procedures.

Emergency Care: Critical for rapid sequence intubation (RSI) in trauma, cardiac arrest, or respiratory failure scenarios where airway control is urgent.

ICU Intubation: Assists with intubation of critically ill patients requiring mechanical ventilation, including those with difficult airway anatomy.

Pediatric & Neonatal Care: Size-adapted stylets for gentle intubation of infants and children with delicate airway structures.

Pre-Hospital Settings: Essential for paramedics and emergency medical technicians (EMTs) performing field intubations in ambulances or rescue sites.

 

Certifications: Complies with ISO 13485, CE, and NMPA medical device standards. Each production batch undergoes flexibility and shape retention testing to verify core performance, sheath smoothness and biocompatibility assessments (cytotoxicity, sensitization), dimensional accuracy checks to match ETT sizes, and sterility validation for EO-sterilized units. Unique batch number is assigned for full production and distribution traceability, and detailed Instruction for Use (IFU) is included with each package.

1.Packing: Individual sterile paper-plastic composite packaging with peel-open seal; each package is labeled with size, compatibility, sterilization date, and expiration date. Bulk transport in sturdy corrugated cartons with anti-crush dividers to prevent bending of stylet cores.

2.Storage: Store in a clean, dry, well-ventilated environment (temperature 10℃~40℃, relative humidity ≤80%). Avoid direct sunlight, high heat, or contact with sharp objects. Do not open packaging until immediately before use.

3.Handling: For single-patient use only-do not reuse, reprocess, or share to prevent cross-infection. Inspect the package for tears or damage before use; discard if sterility is compromised. Shape the stylet to the desired curvature before inserting into the endotracheal tube; do not over-bend the core to avoid breakage.

4.Transportation: Transport in accordance with medical device transportation regulations. Protect from violent collision, compression, or moisture to preserve product sterility and structural integrity of the stylet core.

Zhejiang Mediunion Healthcare Group Co. Ltd. (a branch of Evergrand Healthcare Group, founded in 2014) is located in Ningbo City, Zhejiang Province - enjoying an excellent location and convenient transportation. Our business covers medical device manufacturing & sales, plus investments in nursing homes, dental clinics, specialist hospitals and medical care services. Our products are sold worldwide, and we've won global consumer recognition with high-quality goods and comprehensive after-sales service.

Diversified Product Portfolio

Our product range includes disposable medical consumables, medical equipment and non-woven products (e.g. dental supplies, respiratory care items). This diverse lineup caters to the needs of medical institutions, clinics and other clients.

Reliable Supply & Collaboration

We have rich industry experience and partner with over 600 factories. These partners are equipped with advanced production equipment and skilled frontline staff, enabling us to produce customized products/components as per specific requests.

Strict Quality Assurance

We prioritize innovation & quality, backed by the ISO 13485:2016 quality management system. Strict control runs through raw material procurement, mass production, process management and finished product release. Our professional services (production control, order follow-up, delivery) also set us apart.

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