Intended purpose of use: for piercing foetal skull and reduce its diameter in case of death in uterus, in order to permit vaginal extraction.
Product description: Perforator, Smellie is a destructive tool used to pierce the skull of a dead foetus.
Material: Martensitic steel (quenched, magnetic steel).
Cuts by perforating shears. composition: 0.40 % carbon; 14% chromium.
Length: approx. 250mm.
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 pierce foetal skull and reduce its diameter in case of death in uterus, in order to permit vaginal extraction.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
One (1) perforator 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 revision of standards):
ISO 7153-1:1991.
ISO 17664:2004.
ISO 13402:1995.
ISO 7741:1986.
BS 5194-4:1985.
Product description: Perforator, Smellie is a destructive tool used to pierce the skull of a dead foetus.
Material: Martensitic steel (quenched, magnetic steel).
Cuts by perforating shears. composition: 0.40 % carbon; 14% chromium.
Length: approx. 250mm.
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 pierce foetal skull and reduce its diameter in case of death in uterus, in order to permit vaginal extraction.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
One (1) perforator 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 revision of standards):
ISO 7153-1:1991.
ISO 17664:2004.
ISO 13402:1995.
ISO 7741:1986.
BS 5194-4:1985.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $15.22 |
