Intended purpose of use: used for lubrication of the O-ring of Ipas MVA Plus aspirator.
Product description: Medical grade silicone.
Components:
Tube (volume 2 ml of 2cc) containing lubricant.
Lubricant: Silicone.
Tube: The top of tube is removed so the silicone can be removed. Material polypropylene.
Cap: Part which is pressed onto the top of the tube to prevent silicone from leaking out of the tube. Material polypropylene.
Non-sterile.
Instructions for use:
Lubricant applied to the O-ring to ease Ipas MVA Plus aspirator plunger movement.
Packaging & Labelling:
Pack of ten (10) silicone 2cc tubes.
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:
Must comply with the following standards:
ISO 13485: 2016 Quality management systems -- Requirements for regulatory purposes.
ISO 14971:2007 Medical Devices- Application of risk management to medical devices.
Environmental requirements: ISO 14001.
Product description: Medical grade silicone.
Components:
Tube (volume 2 ml of 2cc) containing lubricant.
Lubricant: Silicone.
Tube: The top of tube is removed so the silicone can be removed. Material polypropylene.
Cap: Part which is pressed onto the top of the tube to prevent silicone from leaking out of the tube. Material polypropylene.
Non-sterile.
Instructions for use:
Lubricant applied to the O-ring to ease Ipas MVA Plus aspirator plunger movement.
Packaging & Labelling:
Pack of ten (10) silicone 2cc tubes.
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:
Must comply with the following standards:
ISO 13485: 2016 Quality management systems -- Requirements for regulatory purposes.
ISO 14971:2007 Medical Devices- Application of risk management to medical devices.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 10 | $4.75 |
