Monik™ Disposable Endoscopic Trocar

Dénomination commerciale

Monik™ Disposable Endoscopic Trocar

18904255200262

89042552MES_DET36TT

Numéro de référence/catalogue

ME/BRC/037

GS1

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Disposable Endoscopic Trocar is sterile single patient use instrument consisting of a radiolucent sleeve and obturator in sizes 5 mm, 10 mm and 12mm and 15 mm diameter. The obturator contains a clear tapered optical element. The 5 mm, 10mm 12 mm and 15 mm diameter obturators accommodate an appropriately sided 0° endoscope and provide visibility of individual tissue layers during insertion. The trocar sleeves for t e 5 mm, 10 mm, 12mm and 15 mm devices contain two seals. An outer integrated removable self-adjusting seal that accommodates instruments ranging from 5 mm to 15 mm in diameter where indicated and an internal seal. Together these two seals minimize gas leakage when instruments are inserted or withdrawn through the seals minimize gas leakage when instruments are inserted or withdrawn through the and accommodates only 5 mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• K01010101TROCAR STANDARD, SINGLE-USE

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• Consulter la notice d’utilisation

  "● Minimally invasive procedures should be performed only by persons having adequate training and familiarity with minimally invasive techniques. Consult medical literature relative to techniques, complications, and hazards prior to performance of any minimally invasive procedure. ● Minimally invasive instruments may vary in diameter from manufacturers to manufacturer. When minimally invasive instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility prior to initiation of the procedure. ● A thorough understanding of the principles and techniques involved in laser, electro surgical, and ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical instruments. Ensure that electrical insulation or grounding is not compromised. Do not immerse electro surgical instruments in liquid unless the instruments are designed and labelled to be immersed. ● Using minimally invasive instruments with a diameter smaller than specified for the Bladeless Trocar may result in desufflation of the abdominal cavity."