Product Description:
EasyGrip cannulae combined with MVA are used for uterine aspiration/ uterine evacuation in obstetrics and gynaecology patients. Applications o MVA includes:
- treatment of incomplete abortion for uterine sizes up to 12 weeks from the last menstrual period (LMP)
- endometrial biopsy
Tubular device with integrated winged adapted , colour code by size
Semi-rigid.
Supplied as initially sterile.
Reusable.
Sterilization method: ethylene oxide or gamma radiation.
Diameter: 4 mm (indicated by a number in the cannulae)
Length: 22.5 - 24 cm
Two opposing apertures at the end of the cannulae
Printed insertion guides: six marking dots , starting 6 cm form the tip, spaced 1 cm.
Intended use:
EasyGrip cannulae combined with Ipas MVA Plus Aspirator are used for uterine aspiration/ uterine evacuation in obstetrics and gynaecology patients.
Select appropriate Easy Grip cannulae.
Cannulae are supplied as sterile but can be reused after the first use.
Reusable items must be mechanically cleaned, disinfected and sterilized between patients.
Cannulae should be stored in dry, covered containers or packages, protected form contaminants.
Supplied with:
Manufacturer´s instruction for use, assembly/disassembly and maintenance in English/French and Spanish.
Accessories / Spare Parts / Consumables (available but not supplied):
Ipas MVA Plus Aspirator with 2cc Silicone tube.
Accesory kit for MVA incl. Plunger O-ring, Collar stop, Cap and 2cc Silicone tube.
Packaging and labelling:
Packaging: One (1) cannula in an individual sterilised peel-off pack made of paper and/or plastic.
Label includes:
Name and/ or trade name, and address of the manufacturer.
Manufacturer's product reference.
The word"sterile" (or equivalent harmonised symbol).
Sterilisation method (or equivalent harmonised symbol).
Lot number prefixed by the word "LOT" (or equivalent harmonised symbol).
Expiry date: month and year.
The words "check the integrity of the individual sterilisation protection before use" (if space allows).
The word "don´t use if the packaging is damag" (or equivalent harmonized symbol).
CE marking and Notified Body number.
Symbols used according ISO 15223 and EN 980.
Regulation & 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 certified.
Classification:
Class IIa - Rule 5: Invasive accessory device, short term use (MDD 93/42/EEC, MDR 2017/745)
Safety & product Standards (current version of the following standards):
ISO 14971: Medical Devices- Application of risk management to medical devices.
ISO 11135: Sterilization of health-care products - Ethylene oxide, or equivalent corresponding to sterilization method.
ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 11607-2: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 17664: Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices.
Environmental requirements:
Not use PVC polymer
EasyGrip cannulae combined with MVA are used for uterine aspiration/ uterine evacuation in obstetrics and gynaecology patients. Applications o MVA includes:
- treatment of incomplete abortion for uterine sizes up to 12 weeks from the last menstrual period (LMP)
- endometrial biopsy
Tubular device with integrated winged adapted , colour code by size
Semi-rigid.
Supplied as initially sterile.
Reusable.
Sterilization method: ethylene oxide or gamma radiation.
Diameter: 4 mm (indicated by a number in the cannulae)
Length: 22.5 - 24 cm
Two opposing apertures at the end of the cannulae
Printed insertion guides: six marking dots , starting 6 cm form the tip, spaced 1 cm.
Intended use:
EasyGrip cannulae combined with Ipas MVA Plus Aspirator are used for uterine aspiration/ uterine evacuation in obstetrics and gynaecology patients.
Select appropriate Easy Grip cannulae.
Cannulae are supplied as sterile but can be reused after the first use.
Reusable items must be mechanically cleaned, disinfected and sterilized between patients.
Cannulae should be stored in dry, covered containers or packages, protected form contaminants.
Supplied with:
Manufacturer´s instruction for use, assembly/disassembly and maintenance in English/French and Spanish.
Accessories / Spare Parts / Consumables (available but not supplied):
Ipas MVA Plus Aspirator with 2cc Silicone tube.
Accesory kit for MVA incl. Plunger O-ring, Collar stop, Cap and 2cc Silicone tube.
Packaging and labelling:
Packaging: One (1) cannula in an individual sterilised peel-off pack made of paper and/or plastic.
Label includes:
Name and/ or trade name, and address of the manufacturer.
Manufacturer's product reference.
The word"sterile" (or equivalent harmonised symbol).
Sterilisation method (or equivalent harmonised symbol).
Lot number prefixed by the word "LOT" (or equivalent harmonised symbol).
Expiry date: month and year.
The words "check the integrity of the individual sterilisation protection before use" (if space allows).
The word "don´t use if the packaging is damag" (or equivalent harmonized symbol).
CE marking and Notified Body number.
Symbols used according ISO 15223 and EN 980.
Regulation & 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 certified.
Classification:
Class IIa - Rule 5: Invasive accessory device, short term use (MDD 93/42/EEC, MDR 2017/745)
Safety & product Standards (current version of the following standards):
ISO 14971: Medical Devices- Application of risk management to medical devices.
ISO 11135: Sterilization of health-care products - Ethylene oxide, or equivalent corresponding to sterilization method.
ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 11607-2: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 17664: Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices.
Environmental requirements:
Not use PVC polymer
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1.51 |
