Intended purpose of use: For injection and various other uses, including mixing.
Product description: Syringe, two pieces: barrel with Luer nozzle and piston/plunger of three pieces: barrel with luer nozzle, stopper and piston/plunger.
Capacity: 10 ml, supplied without needle.
BARREL with finger tip: Materials: medical grade PE (polyethylene) of PP (polypropylene); Graduated scale on the barrel, with scale interval of 0.5 and 1.0ml increment between graduation lines to be numbered. Barrel sufficiently transparent to allow easy measurement of the volume contained in the syringe and detection of air bubbles.
Concentric of eccentric luer nozzle for 10 ml capacity.
piston/plunger : Medical grade polypropylene, fit to slide easily and smoothly inside the barrel
stopper (for 3-piece syringe): Material is elastomer, medical grade, Located at the end of the plunger, Ensures a secure and safe seal.
Sterile and disposable.
Sterilization method: ethylene oxide.
Shelf life 5 years.
Instructions for use.
Injection safety:
The syringe is sterile, ready for immediate use and is for single use ONLY.
Check the integrity of the packaging before opening.
Do not use the syringe if the packaging is not sealed of is pierced.
NEVER recap the needle after use and IMMEDIATELY dispose of the mounted syringe and needle into a puncture-proof safety container.
Supplied with:
Manufacturer's instruction for use, indications for use, contraindications, warnings, precautions for use, storage conditions, disposal instructions etc shall be provided.
Packaging and labelling as per regulations applied to the device:
Primary packaging: each syringe bi-packed in an individual sterilized peel-off pack made of paper and/of plastic.
Secondary packaging: Protective packaging - 1 carton of 100 bi-packed syringes.
Symbols used according ISO 15223.
CE Mark with Notified Body number.
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 Is device.
Safety & product Standards:
Must comply with the following standards (must comply with latest revision of standards):
EN ISO 7886-1: 2017: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular of hypodermic applications.
ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
Environmental requirements: ISO 14001.
Product description: Syringe, two pieces: barrel with Luer nozzle and piston/plunger of three pieces: barrel with luer nozzle, stopper and piston/plunger.
Capacity: 10 ml, supplied without needle.
BARREL with finger tip: Materials: medical grade PE (polyethylene) of PP (polypropylene); Graduated scale on the barrel, with scale interval of 0.5 and 1.0ml increment between graduation lines to be numbered. Barrel sufficiently transparent to allow easy measurement of the volume contained in the syringe and detection of air bubbles.
Concentric of eccentric luer nozzle for 10 ml capacity.
piston/plunger : Medical grade polypropylene, fit to slide easily and smoothly inside the barrel
stopper (for 3-piece syringe): Material is elastomer, medical grade, Located at the end of the plunger, Ensures a secure and safe seal.
Sterile and disposable.
Sterilization method: ethylene oxide.
Shelf life 5 years.
Instructions for use.
Injection safety:
The syringe is sterile, ready for immediate use and is for single use ONLY.
Check the integrity of the packaging before opening.
Do not use the syringe if the packaging is not sealed of is pierced.
NEVER recap the needle after use and IMMEDIATELY dispose of the mounted syringe and needle into a puncture-proof safety container.
Supplied with:
Manufacturer's instruction for use, indications for use, contraindications, warnings, precautions for use, storage conditions, disposal instructions etc shall be provided.
Packaging and labelling as per regulations applied to the device:
Primary packaging: each syringe bi-packed in an individual sterilized peel-off pack made of paper and/of plastic.
Secondary packaging: Protective packaging - 1 carton of 100 bi-packed syringes.
Symbols used according ISO 15223.
CE Mark with Notified Body number.
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 Is device.
Safety & product Standards:
Must comply with the following standards (must comply with latest revision of standards):
EN ISO 7886-1: 2017: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular of hypodermic applications.
ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $3.96 |
