Intended purpose of use: Designed to place ligatures around vessels in poorly accessible sites. Use to place, mobilize and tie suture threads around blood vessels of aneurysms, in order to achieve adequate haemostasis.
Product description:
Designed to place ligatures around vessels in poorly accessible sites.
Long thin instrument with a palm-held handle and a thin needle-like extension which, at its tip, bends laterally at right angles and then describes a semicircle in the same plane. The tip has a needle eye and a pointed but not sharp end. Designed to place ligatures around vessels in poorly accessible sites.
Made of stainless steel ( medical grade).
Curved left, for right hand.
Needle, pointed 20cm.
Dimensions: width – 1.5cm; height: 21cm; diameter: 1 cm.
Supplied non sterile, Hygienically packed for medical use after sterilization.
Reusable: Can withstand repeated reprocessing including steam sterilization, including manual brushing and the use of disinfectant chemicals.
Supplied with:
Manufacturer's instruction for use.
Instructions for use:
Used to place ligatures around vessels in poorly accessible sites.
retract the lips of an incision of a deep vaginal wound.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
One (1) Hook in a plastic bag.
Symbols used according ISO 15223.
CE mark with Notified Body number.
Labelling shall be as per regulations applied to the device.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class IIa device.
Safety & product Standards:
Must comply with the following standards (as per latest revision of standards):
ISO 14971:2007 Medical Devices- Application of risk management to medical devices.
ISO 7153-1:1991/Amd1:1999 Surgical instruments- Metallic material – Part 1 Stainless Steel.
ISO 7151:1988 Surgical instruments -- Non-cutting, articulated instruments -- General requirements and test methods.
ISO 13402:1995 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure.
ISO 17664:2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices.
Environmental requirements: ISO 14001.
Product description:
Designed to place ligatures around vessels in poorly accessible sites.
Long thin instrument with a palm-held handle and a thin needle-like extension which, at its tip, bends laterally at right angles and then describes a semicircle in the same plane. The tip has a needle eye and a pointed but not sharp end. Designed to place ligatures around vessels in poorly accessible sites.
Made of stainless steel ( medical grade).
Curved left, for right hand.
Needle, pointed 20cm.
Dimensions: width – 1.5cm; height: 21cm; diameter: 1 cm.
Supplied non sterile, Hygienically packed for medical use after sterilization.
Reusable: Can withstand repeated reprocessing including steam sterilization, including manual brushing and the use of disinfectant chemicals.
Supplied with:
Manufacturer's instruction for use.
Instructions for use:
Used to place ligatures around vessels in poorly accessible sites.
retract the lips of an incision of a deep vaginal wound.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
One (1) Hook in a plastic bag.
Symbols used according ISO 15223.
CE mark with Notified Body number.
Labelling shall be as per regulations applied to the device.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class IIa device.
Safety & product Standards:
Must comply with the following standards (as per latest revision of standards):
ISO 14971:2007 Medical Devices- Application of risk management to medical devices.
ISO 7153-1:1991/Amd1:1999 Surgical instruments- Metallic material – Part 1 Stainless Steel.
ISO 7151:1988 Surgical instruments -- Non-cutting, articulated instruments -- General requirements and test methods.
ISO 13402:1995 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure.
ISO 17664:2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $4.92 |
