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LINEAR STAPLER, reloadable, thick tissues, 60mm (TX60G)

https://unicat.msf.org/cat/product/75087
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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.
H020201010102 - Single patient straight linear staplers without 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 STAPLER, reloadable

Definition

A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue; it has no cutting function. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.

Specifications

  • The linear stapler poses two rows of staggered titanium staples to bring the internal tissues together. The stapler is available in two stapling lengths to fit different tissues (30 and 60 mm).
  • The vascular linear stapler has three rows of staggered titanium staples over a length of 30 mm.
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Technical specifications

  • Parallel jaw closure for consistent staple formation
  • Designed for one handed operation (close, fire, release)
  • Intermediate locking position for easy tissue placement
  • Heavy wire staples
  • Staples only, does not cut the tissue between the rows of staples.
  • Can be reloaded up to seven times for a maximum of eight firings (=including the initial load)
  • Sterile, for single use

Material of the main components:

  • Stapler: Steel - Aluminum - Acrylonitrile-butadiene-styrene - Polyether-polyamide copolymer - Polyamide - Polycarbonate - Polyetherimide - Liquid crystal polymer - Poly (phenylene oxide) - Polytetrafluoroethylene - Polyurethane - Acrylic ink
  • Staples: Biologically and radiologically Inert Titanium-6-Aluminum-4-Vanadium Alloy - Stearate Powder

Staplers

Indication

Rows of staples

Length

TX30V

Vascular Linear stapler

fine and vascular tissues

2x3

30 mm

TX30B

Linear stapler

normal tissues

2x2

30 mm

TX30G

Linear stapler

thick tissues

2x2

30 mm

TX60B

Linear stapler

normal tissues

2x2

60 mm

TX60G

Linear stapler

thick tissues

2x2

60 mm

Sizes of the staples:

reloadcoloursize open stapleheight closed staple
XR30Vwhite3.0 x 2.5 mm1.0 mm
XR30Bblue4.0 x 3.5 mm1.5 mm
XR30Ggreen4.0 x 4.8 mm2.0 mm
XR60Bblue4.0 x 3.5 mm1.5 mm
XR60Ggreen4.0 x 4.8 mm2.0 mm

​

To be Ordered Separately

The staplers are supplied previously loaded. Additional reloads are to be ordered separately.

Staple reloads

Indication

Row of staples

Length

XR30V

Charger for TX30V

fine and vascular tissues

2x3

30 mm

XR30B

Charger for TX30B / TX30G

normal tissues

2x2

30 mm

XR30G

Charger for TX30G / TX30B

thick tissues

2x2

30 mm

XR60B

Charger for TX60B / TX60G

normal tissues

2x2

60 mm

XR60G

Charger for TX60G / TX60B

thick tissues

2x2

60 mm

Instructions for use

The staplers can be reloaded during the same procedure.

Do not refill staplers more than seven times for up to eight staplings.

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Precautions for Use

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

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