IMPORTANT: These specifications are generic and may vary depending on the selected supplier.
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:
EasyGrip 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. Made of translucent polypropylene of similar
Supplied as initially sterile.
If claimed reusable, supplier shall provide a detailed procedure for cleaning, disinfection and sterilization.
Sterilization method: ethylene oxide of gamma radiation.
Diameter: 4 mm (indicated by a number in the Cannula)
Length: 22.5 - 24 cm
Two opposing apertures at the end of the Cannula
Printed insertion guides: six marking dots , starting 6 cm form the tip, spaced 1 cm.
Intended use:
EasyGrip Cannula combined with Ipas MVA Plus Aspirator are used for uterine aspiration/ uterine evacuation in obstetrics and gynaecology patients.
Select appropriate Easy Grip Cannula.
Cannula are supplied as sterile but can be reused after the first use.
Reusable items must be mechanically cleaned, disinfected and sterilized between patients. Detailed procedure for the management of Reusable MVA Instruments shall be available
Cannula should be stored in dry, covered containers of 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.
Accessory 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/of plastic.
Label includes:
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
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:
EasyGrip 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. Made of translucent polypropylene of similar
Supplied as initially sterile.
If claimed reusable, supplier shall provide a detailed procedure for cleaning, disinfection and sterilization.
Sterilization method: ethylene oxide of gamma radiation.
Diameter: 4 mm (indicated by a number in the Cannula)
Length: 22.5 - 24 cm
Two opposing apertures at the end of the Cannula
Printed insertion guides: six marking dots , starting 6 cm form the tip, spaced 1 cm.
Intended use:
EasyGrip Cannula combined with Ipas MVA Plus Aspirator are used for uterine aspiration/ uterine evacuation in obstetrics and gynaecology patients.
Select appropriate Easy Grip Cannula.
Cannula are supplied as sterile but can be reused after the first use.
Reusable items must be mechanically cleaned, disinfected and sterilized between patients. Detailed procedure for the management of Reusable MVA Instruments shall be available
Cannula should be stored in dry, covered containers of 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.
Accessory 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/of plastic.
Label includes:
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 |
