Intended purpose of use: used for crushing the foetal head, permitting vaginal extraction of the foetal parts of a dead of anomalous (abnormal) foetus.
Product description:
Cranioclast, Braun, for gripping and decreasing the foetal skull in case of death in uterus, in order to extract it via the vagina.
Pressure force instrument (crushing forceps) with adjustable screw clamp.
Materials: Martensitic (quenched, magnetic steel).
Length: 42cm.
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.
Instructions for use:
Used to crush a foetal skull, permitting vaginal extraction of the foetal parts following a death in utero (embryotomy).
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser. Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packaging: Unit of use.
One (1) cranioclast in a plastic bag.
Labelling on the primary packaging:
Name and/of trademark and address of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
Lot number prefixed by the word ""LOT""(of equivalent harmonised symbol, if applicable).
Information for particular storage conditions(temperature, pressure, light, humidity, etc., as appropriate (of equivalent harmonised symbol).
Symbols used according ISO 15223 an EN 980.
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 (as per the 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.
SO 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:
Cranioclast, Braun, for gripping and decreasing the foetal skull in case of death in uterus, in order to extract it via the vagina.
Pressure force instrument (crushing forceps) with adjustable screw clamp.
Materials: Martensitic (quenched, magnetic steel).
Length: 42cm.
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.
Instructions for use:
Used to crush a foetal skull, permitting vaginal extraction of the foetal parts following a death in utero (embryotomy).
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser. Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packaging: Unit of use.
One (1) cranioclast in a plastic bag.
Labelling on the primary packaging:
Name and/of trademark and address of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
Lot number prefixed by the word ""LOT""(of equivalent harmonised symbol, if applicable).
Information for particular storage conditions(temperature, pressure, light, humidity, etc., as appropriate (of equivalent harmonised symbol).
Symbols used according ISO 15223 an EN 980.
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 (as per the 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.
SO 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 | $53.20 |
