Disposable Endo Cutter and Cartridges

Dénomination commerciale

Disposable Endo Cutter and Cartridges

Code d'IUD-ID

06954790917908

IUD-ID de base

B-06954790917908

Numéro de référence/catalogue

TCZNXK-60G

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

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.

• H02030199LINEAR STAPLERS FOR VIDEOSURGERY - OTHER
• H02020199LINEAR STAPLERS FOR OPEN SURGERY - OTHER

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• CW999

  1.The endo stapler is disposable and can be used after opening the sterile package. Once the package is found to be damaged, it must not be used. When in use, the sterile techique shall be strictly executed. 2.The endo stapler is sterilized by ethylene oxide, and is delivered in a sterile sealed package. The validity period is three years from the date of sterilization. Products beyond the validity period are strictly prohibited to use. 3.The maximum number of firing of the stapler is 8 times. In the same operation, replaceable reloads, and it can be fired continuously for 8 times. Reload shall not be replaced more than the maximum number of percussion. The use of stapler in conjunction with anastomotic line reinforcement materials may reduce the number of percussion. 4.During abdominal surgery, if a proper pneumoperitoneum cannot be formed and maintained, it may reduce the available operating space and increase the risk of visceral tissue injury. 5.MRI magnetic resonance compatibility and limited use conditions: The staple is made of pure titanium material, which is not affected by MRI magnetic resonance interference. 6.Type Ⅱ stapler: Before reinstalling the reload, the used stapler is rinsed with sterile solution and wiped against the anvil and the jaws of the cartridges to remove all the formed but unused staples from the device. The instrument can only be used after no staple in the anvil and the jaw of the cartridge is confirmed through visual inspection. 7.This instruction for use is only a general introduction to the use of the stapler, and is not for surgical guidance. The surgeon must refer to the relevant medical literature and related surgical atlas during the operation.

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.