Product Description:
Bierer ovum forceps are for obstetrics / gynecological 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: 16 mm (+/- 5%)
Supplied with:
Manufacturer's instructions for use, cleaning, disinfection and sterilization in English, French and Spanish.
Intended use:
Used for obstetrics / gynecological 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 or 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 or contraindications.
Symbols used according ISO 15223.
CE mark.
Regulation and Conformity Requirements:
CE mark (conforming to Medical Device Directive MDD 93/42/EEC, MDR 2017/745) or FDA 510k approved or equivalent.
Declaration of Conformity according to ISO 17050.
ISO 13485
Classification:
Class I (MDD 93/42/EEC)
Class I - reusable surgical instrument (MDR 2017/745)
Safety and Product Standards (current versions of the following standards):
ISO 7153-1: Surgical instruments - Materials - Part 1: Metals.
ISO 7151: Surgical instruments - Non-cutting, articulated instruments - General requirements and test methods.
ISO 17664: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
ISO 13402: Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure.
Environmental Requirements:
ISO 14001: Environmental management systems
Bierer ovum forceps are for obstetrics / gynecological 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: 16 mm (+/- 5%)
Supplied with:
Manufacturer's instructions for use, cleaning, disinfection and sterilization in English, French and Spanish.
Intended use:
Used for obstetrics / gynecological 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 or 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 or contraindications.
Symbols used according ISO 15223.
CE mark.
Regulation and Conformity Requirements:
CE mark (conforming to Medical Device Directive MDD 93/42/EEC, MDR 2017/745) or FDA 510k approved or equivalent.
Declaration of Conformity according to ISO 17050.
ISO 13485
Classification:
Class I (MDD 93/42/EEC)
Class I - reusable surgical instrument (MDR 2017/745)
Safety and Product Standards (current versions of the following standards):
ISO 7153-1: Surgical instruments - Materials - Part 1: Metals.
ISO 7151: Surgical instruments - Non-cutting, articulated instruments - General requirements and test methods.
ISO 17664: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
ISO 13402: Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure.
Environmental Requirements:
ISO 14001: Environmental management systems
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $18.07 |
