Shepard Grommet Ear Ventilation Tube 1.14mm
Part No.: 23-40100-S
Packaging: Box Contains 10 Pieces
Manufacturer: INVOTEC
Country of Origin: USA
The Shepard Grommet Ear Ventilation Tube is a sterile, precision-engineered medical implant designed for the surgical management of chronic otitis media with effusion (OME) and eustachian tube dysfunction. With an internal diameter of 1.14mm, this tube facilitates middle ear ventilation, equalizing pressure and preventing fluid accumulation. Manufactured from fluoroplastic (FLPL), it combines biocompatibility with mechanical durability, making it suitable for both pediatric and adult patients. The Shepard-style design features a flanged collar for secure placement in the tympanic membrane, ensuring optimal retention and function during its indwelling period.
Features:
Design & Material Specifications:
- Internal Diameter (ID): 1.14 mm.
- Material: Medical-grade fluoroplastic (FLPL) – Non-reactive, MRI-compatible, and resistant to biofilm formation.
- Style: Shepard grommet with flanged collar – Anchors securely in the tympanic membrane.
- Sterility: Individually sterile-packed (Ethylene Oxide or gamma sterilized).
Functional Attributes:
- Pressure Equalization: Restores middle ear ventilation, resolving conductive hearing loss secondary to effusion.
- Minimally Invasive Profile: 1.14mm ID optimizes airflow while minimizing trauma to the eardrum.
- Compatibility: Suitable for use with standard myringotomy techniques and instrumentation.
Indications:
- Chronic OME (>3 months duration).
- Recurrent acute otitiChronic OME (>3 months duration).
- Recurrent acute otitis media (≥3 episodes in 6 months).
- Eustachian tube dysfunction refractory to medical therapy.
Durability & Safety:
- Autoclavable: Can withstand sterilization cycles if repositioning is required (though single-use is recommended).
- Biocompatibility: Complies with ISO 10993-1 for biological safety.
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