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(cutting linear stapler NTLC75) RELOAD, 118 staples (SR75)

https://msf.oodin.sh/cat/product/75094
STD SSUTLISC101

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
H0202010301 - Single-patient linear suture cartdriges with blade for open surgery
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
III
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
PM
The order of this product needs to be justified and is only acceptable under certain conditions.
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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LINEAR CUTTING STAPLER, staple height selectable

Definition

A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it cuts the tissues and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade are housed in a single-use loading unit (SULU) which is not included. This is a single-use device.

Specifications

The stapler has six staggered rows of staples, three on each side of the section line. The height of the staple can be chosen to take into account various thicknesses of tissues with a single loader. The offered staple height adjustment feature allows you to use a single loader to form staples with a closed height of 1.5, 1.8 or 2 mm (use of a select button).

The stapler is shipped without charger set up.

The reload has 75 mm stapler has a 81 mm staple line and a section line of 78 mm.

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Technical specifications

STAPLER

  • Adjustable staple height loader
  • Selection button for staple height closed /
    • 1.5 mm (blue)
    • 1,8 mm (gold)
    • 2.0 mm (green)
  • Safety interlock to prevent its triggering
    • in the absence of a charger
    • if a used loader is put in place
  • Sterile, for single use

RELOAD (staples)

  • SR75 (for use with the NTLC75 stapler)
  • ​Number of staples: 118
  • Six rows of staples with a knife built into it
  • Protective cover on the feeder to protect the staples during shipment and transport
  • Implantable staple made of titanium alloy
  • Length staple: 75mm
  • Sterile, for single use

To be Ordered Separately

The stapler and the reloads have to be ordered separately, the stapler comes WITHOUT staples!

Instructions for use

The stapler can be reloaded during a single operation.

Do not refill the stapler more than twelve times for up to twelve stapler firings.

Read the FDA recommendations: Safe Use of Surgical Staplers and Staples

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