Intended purpose of use: Dilator is a plastic, lightweight instrument used in gynaecological procedures for dilating the cervix.
Product description:
Set of five double-ended, tapered dilators are accessories for Ipas MVA Plus aspirator.
Set of five different size plastic dilators.
Graduated, lightweight.
Material: Polypropylene plastic (medical grade, latex-free).
Length: 29 cm of 11.5 in (+/- 5%).
Sizes: 5/6 mm (one end has 5 mm tapered tip and the other end has a 6 mm tapered tip), 7/8 mm, 9/10 mm, 11/12 mm, and 13/14 mm.
Non-sterile, reusable. If claimed reusable, supplier shall provide a detailed procedure for cleaning, disinfection and sterilization.
Hygienically packed for medical use.
Instruction for use:
Prior to use dilators must be sterilized of high-level disinfected before each use as per manufacturer's instructions (e.g. steam autoclave).
Packaging & Labelling:
Five (5) different size dilators per pack. Name and/ of trade name, and address of the manufacturer.
Manufacturer's product reference.
Lot number prefixed by the word "LOT" (of equivalent harmonised symbol).
Expiry date: month and year.
Symbols used according ISO 15223. Labelling shall be as per the regulations applied to the device.
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: (All standards shall be current).
Must comply with the following standards:
ISO 13485 Medical devices -Quality management systems -- Requirements for regulatory purposes.
ISO 14971 Medical Devices- Application of risk management to medical devices.
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Environmental requirements: ISO 14001.
Product description:
Set of five double-ended, tapered dilators are accessories for Ipas MVA Plus aspirator.
Set of five different size plastic dilators.
Graduated, lightweight.
Material: Polypropylene plastic (medical grade, latex-free).
Length: 29 cm of 11.5 in (+/- 5%).
Sizes: 5/6 mm (one end has 5 mm tapered tip and the other end has a 6 mm tapered tip), 7/8 mm, 9/10 mm, 11/12 mm, and 13/14 mm.
Non-sterile, reusable. If claimed reusable, supplier shall provide a detailed procedure for cleaning, disinfection and sterilization.
Hygienically packed for medical use.
Instruction for use:
Prior to use dilators must be sterilized of high-level disinfected before each use as per manufacturer's instructions (e.g. steam autoclave).
Packaging & Labelling:
Five (5) different size dilators per pack. Name and/ of trade name, and address of the manufacturer.
Manufacturer's product reference.
Lot number prefixed by the word "LOT" (of equivalent harmonised symbol).
Expiry date: month and year.
Symbols used according ISO 15223. Labelling shall be as per the regulations applied to the device.
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: (All standards shall be current).
Must comply with the following standards:
ISO 13485 Medical devices -Quality management systems -- Requirements for regulatory purposes.
ISO 14971 Medical Devices- Application of risk management to medical devices.
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 5 | $29.27 |
