IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: Tubular device available in different lengths and diameters with integrated winged adapter, intended for insertion into the uterine cavity for evacuation of uterine content.
Product description:
Easy Grip Cannula 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.
Material: Medical grade, latex-free, polypropylene plastic.
Sterile, single use.
Diameter: 7 mm (indicated by a number in the Cannula).
Length: 24 cm of 9.5 in (+/- 5%).
Two opposing apertures at the end of the Cannula (4-8 mm).
Printed insertion guides: six marking dots starting at 6 cm from the tip and spaced 1 cm apart. If claimed reusable, supplier shall provide a detailed procedure for cleaning, disinfection and sterilization.
Instructions for use:
Easy Grip Cannula 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
Select appropriate Easy Grip Cannula.
Reusable items must be cleaned, disinfected and sterilized between patients and sterilized. Detailed procedure for the management of Reusable MVA Instruments shall be available
Don't use ""flash"" setting. Don't use higher temperatures as damage may occur.
Cannula should be stored in dry, covered containers of packages, protected form contaminants
Supplied with:
- 1x manufacture´s instruction for use, assembly/disassembly and maintenance in English.
Accessories/ spare parts/consumables:
- MVA Aspirator
Packaging and labelling:
Packaging: 1 Cannula bi-packed in an individual sterilised peel-off pack made of paper and/of plastic.
Labelling
Name and/ of trade name, and address of the manufacturer.
Manufacturer's product reference.
The word ""sterile"" (of equivalent harmonised symbol).
Sterilisation method (of equivalent harmonised symbol).
Lot number prefixed by the word ""LOT"" (of 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 damage"" (of equivalent harmonized symbol)
CE marking and Notified Body number
Symbols used according ISO 15223 and EN 980
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 IIa device
Environmental requirements:
ISO 14001
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: Tubular device available in different lengths and diameters with integrated winged adapter, intended for insertion into the uterine cavity for evacuation of uterine content.
Product description:
Easy Grip Cannula 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.
Material: Medical grade, latex-free, polypropylene plastic.
Sterile, single use.
Diameter: 7 mm (indicated by a number in the Cannula).
Length: 24 cm of 9.5 in (+/- 5%).
Two opposing apertures at the end of the Cannula (4-8 mm).
Printed insertion guides: six marking dots starting at 6 cm from the tip and spaced 1 cm apart. If claimed reusable, supplier shall provide a detailed procedure for cleaning, disinfection and sterilization.
Instructions for use:
Easy Grip Cannula 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
Select appropriate Easy Grip Cannula.
Reusable items must be cleaned, disinfected and sterilized between patients and sterilized. Detailed procedure for the management of Reusable MVA Instruments shall be available
Don't use ""flash"" setting. Don't use higher temperatures as damage may occur.
Cannula should be stored in dry, covered containers of packages, protected form contaminants
Supplied with:
- 1x manufacture´s instruction for use, assembly/disassembly and maintenance in English.
Accessories/ spare parts/consumables:
- MVA Aspirator
Packaging and labelling:
Packaging: 1 Cannula bi-packed in an individual sterilised peel-off pack made of paper and/of plastic.
Labelling
Name and/ of trade name, and address of the manufacturer.
Manufacturer's product reference.
The word ""sterile"" (of equivalent harmonised symbol).
Sterilisation method (of equivalent harmonised symbol).
Lot number prefixed by the word ""LOT"" (of 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 damage"" (of equivalent harmonized symbol)
CE marking and Notified Body number
Symbols used according ISO 15223 and EN 980
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 IIa device
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1.51 |
