HTML60

Dénomination commerciale

non renseigné

06954862602848

69548626001XW

Numéro de référence/catalogue

HTML60

GS1

Classe IIb

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Powered Articulating Endoscopic Linear Cutter and Reload is sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The Power Stapler and Reload is sterilized by EO. The instruments deliver six staggered rows of staples, three on either side of the cut line. The power stapler available in three shaft lengths: S, M, L, two stapler line length: 45 and 60, optional eagle beak (HT___Y). The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The Reload is divided into two types: HTF and HTG, the difference between the two types is whether the surface of the staple cartridge is rough (HTG) or not (HTF). The reload available in two stapler line length: 45 and 60, six staple heights.

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.

• H020301050101SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR THORACOSCOPY
• H020301050102SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR LAPAROSCOPY
• H02030106LINEAR STAPLER CARTRIDGES FOR VIDEOSURGERY

3 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW999

  • Do not use the instruments on the aorta. • Do not use the instruments on major vessels. • Tissue thickness should be carefully evaluated before firing the stapler. Please refer to the reload model table of the Reload below for tissue compression requirements (closed staple height) of each staple size. The tissue may be too thick or too thin for the size of the selected staple so that the tissue cannot be comfortably compressed to the closed staple height, or can be easily compressed to less than the closed staple height. • The instruments should not be used to staple tissues that are necrotic, friable, or have altered integrity, e.g., ischemic or edematous tissues.
• CW009

  The Powered Articulating Endoscopic Linear Cutter and Reload are packaged and sterilized for single use only, and cannot be reused, reprocessed or re-sterilized.
• CW001

  Reuse, re-processing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure that in turn may result in patient injury, illness, or death