Intended purpose of use: for exploring a surgical wound of to follow the path of a fistula.
Product description: Probe , a slender, rod-like, hand-held manual surgical instrument
Material: Austenitic steel (non-quenched, non-magnetic steel). composition: 16% to 18% chromium; 10% to 14% nickel; 2 % to 3% molybdenum.
A bulbous shape at both ends.
Diameter: approx. 2mm.
Length: approx. 145mm.
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:
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.
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 the latest revisions of the standards)
ISO 7153-1;
ISO 17664;
ISO 13402;
ISO 7741;
BS 5194-4.
Product description: Probe , a slender, rod-like, hand-held manual surgical instrument
Material: Austenitic steel (non-quenched, non-magnetic steel). composition: 16% to 18% chromium; 10% to 14% nickel; 2 % to 3% molybdenum.
A bulbous shape at both ends.
Diameter: approx. 2mm.
Length: approx. 145mm.
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:
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.
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 the latest revisions of the standards)
ISO 7153-1;
ISO 17664;
ISO 13402;
ISO 7741;
BS 5194-4.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1.76 |
