IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: for properly removing pieces of the placenta of products of conception from the uterus to prevent infection
Product Description: Bierer ovum forceps are for obstetrics / gynaecological procedures such as removal of placenta fragments from the uterus.
Serrated and fenestrated blades provide a firm grasp.
Material: Martensitic stainless steel (quenched magnetic steel) 0.20% carbon, 13% Chromium.
Gripping forceps with fully serrated jaws (with large 'teeth').
Fenestrated oval jaws.
Slightly curved.
Ring handles.
Non-ratcheted, not lockable.
Highly impact resistant.
Length: 330 mm (+/- 5%)
Size: Small
Jaws: 19 mm (+/- 5%)
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 instructions for use, cleaning, disinfection and sterilization in English, French and Spanish.
Intended use:
Used for obstetrics / gynaecological procedures such as removal of placenta fragments from the uterus.
This item must be cleaned and disinfected after each use, and sterilised in a steam steriliser.
Packaging and Labelling:
One (1) unit in a protective packaging with a label that includes:
Device identity and intended purpose.
Manufacturer's product code of reference number.
Manufacturer identification.
Address of the manufacturing site.
EC Rep identification.
How the device should be used, maintained and stored.
Lot/Batch and MFD.
Any residual device risks, warnings, limitations of contraindications.
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 14971:2007 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
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: for properly removing pieces of the placenta of products of conception from the uterus to prevent infection
Product Description: Bierer ovum forceps are for obstetrics / gynaecological procedures such as removal of placenta fragments from the uterus.
Serrated and fenestrated blades provide a firm grasp.
Material: Martensitic stainless steel (quenched magnetic steel) 0.20% carbon, 13% Chromium.
Gripping forceps with fully serrated jaws (with large 'teeth').
Fenestrated oval jaws.
Slightly curved.
Ring handles.
Non-ratcheted, not lockable.
Highly impact resistant.
Length: 330 mm (+/- 5%)
Size: Small
Jaws: 19 mm (+/- 5%)
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 instructions for use, cleaning, disinfection and sterilization in English, French and Spanish.
Intended use:
Used for obstetrics / gynaecological procedures such as removal of placenta fragments from the uterus.
This item must be cleaned and disinfected after each use, and sterilised in a steam steriliser.
Packaging and Labelling:
One (1) unit in a protective packaging with a label that includes:
Device identity and intended purpose.
Manufacturer's product code of reference number.
Manufacturer identification.
Address of the manufacturing site.
EC Rep identification.
How the device should be used, maintained and stored.
Lot/Batch and MFD.
Any residual device risks, warnings, limitations of contraindications.
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 14971:2007 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 | $17.80 |
