Intended purpose of use: for exploring a surgical wound of to follow the path of a fistula.
Product description:
Probe with eye, malleable, 20 cm.
Probe and dilator.
Bulbous shape, at both ends.
Malleable: length 20cm, thickness 2mm.
Length: approximately 20cm.
Materials: Austenitic steel (non-quenched, non-magnetic steel).
Material composition: 16 -18% chromium; 10-12% nickel: 1% silicon; 2% manganese.
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 explore a surgical wound of to follow the path of a fistula. This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
One (1) probe in a plastic bag.
Symbols used according ISO 15223.
CE mark, Labelling as per regulations applied to the device. Shall include name of the device, name and address of the manufacturer, product code of manufacturers reference number etc.
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 I device.
Safety & product Standards:
Must comply with the following standards (as per latest revision of standards):
ISO 14971 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 Surgical instruments -- Non-cutting, articulated instruments -- General requirements and test methods.
ISO 13402 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure.
ISO 17664 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:
Probe with eye, malleable, 20 cm.
Probe and dilator.
Bulbous shape, at both ends.
Malleable: length 20cm, thickness 2mm.
Length: approximately 20cm.
Materials: Austenitic steel (non-quenched, non-magnetic steel).
Material composition: 16 -18% chromium; 10-12% nickel: 1% silicon; 2% manganese.
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 explore a surgical wound of to follow the path of a fistula. This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
One (1) probe in a plastic bag.
Symbols used according ISO 15223.
CE mark, Labelling as per regulations applied to the device. Shall include name of the device, name and address of the manufacturer, product code of manufacturers reference number etc.
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 I device.
Safety & product Standards:
Must comply with the following standards (as per latest revision of standards):
ISO 14971 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 Surgical instruments -- Non-cutting, articulated instruments -- General requirements and test methods.
ISO 13402 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure.
ISO 17664 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 | $1.29 |
