HTGW60

Trade name

not provided

06954862603104

69548626001XW

Reference / catalog number

HTGW60

GS1

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

2 packaging levels registered — each level carries its own UDI-DI.

• 06954862603104× 1 unitBase unit
  • 16954862603101× 12 units
    • 36954862603105× 4 units

European Medical Device Nomenclature — the EU product classification assigned to this device.

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

3 warnings recorded — scroll inside the panel to see all entries.

• • 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.

  OTHER

• Do not re-use

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

• Do not resterilize

  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.