Intended purpose of use: Obstetrical hook for the vaginal extraction of a dead foetus in utero (embryotomy) meant for use by experienced doctors.
Product description:
Material: Martensitic stainless steel (quenched, magnetic steel) composition: 0.20% carbon; 13% chromium.
Length: approx.310 mm.
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 extract the foetus through the vagina in case of death in uterus.
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 . 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 to the latest revision of standards):
Must comply with the following standards:
ISO 7153-1:1991;
ISO 17664:2004;
ISO 13402:1995;
ISO 7741:1986;
BS 5194-4:1985.
Environmental requirements: ISO 14001.
Product description:
Material: Martensitic stainless steel (quenched, magnetic steel) composition: 0.20% carbon; 13% chromium.
Length: approx.310 mm.
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 extract the foetus through the vagina in case of death in uterus.
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 . 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 to the latest revision of standards):
Must comply with the following standards:
ISO 7153-1:1991;
ISO 17664:2004;
ISO 13402:1995;
ISO 7741:1986;
BS 5194-4:1985.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $10.13 |
