Product description:
Syringe, two pieces: barrel with Luer nozzle and piston of three pieces barrel with luer nozzle, piston and stopper.
Safety Engineered Feature : The syringe has an auto-disable technology feature that passively activates upon starting administration of the prescribed injectable dose to prevent subsequent re-use of the syringe. Various mechanisms either standalone of in combination e.g. Auto Disposable (AD), Reusable Prevention (RUP), Sharp Injury Prevention (SIP), Retractable Needle (RTN) may be considered. Mandatory product compliance standards ISO 7886 and ISO 23908. Primary package consists of an individual blister pack. Pre-sterilized.
Capacity: 10 ml
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.
The Luer nozzle shall be situated centrally.
Material: Polyethylene (PEF) of polypropylene (PP).
Sterile and disposable.
Sterilization method: ethylene oxide.
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.
Packaging and labelling:
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 IIa device
Safety & product Standards:
Must comply with the following standards:
ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 11607-1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN 20594-1:1994, ISO 594-1:1986
EN ISO 7886-1:1997
Product and packaging complies with WHO PQS E08.
Environmental requirements:
Polymer not PVC
Syringe, two pieces: barrel with Luer nozzle and piston of three pieces barrel with luer nozzle, piston and stopper.
Safety Engineered Feature : The syringe has an auto-disable technology feature that passively activates upon starting administration of the prescribed injectable dose to prevent subsequent re-use of the syringe. Various mechanisms either standalone of in combination e.g. Auto Disposable (AD), Reusable Prevention (RUP), Sharp Injury Prevention (SIP), Retractable Needle (RTN) may be considered. Mandatory product compliance standards ISO 7886 and ISO 23908. Primary package consists of an individual blister pack. Pre-sterilized.
Capacity: 10 ml
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.
The Luer nozzle shall be situated centrally.
Material: Polyethylene (PEF) of polypropylene (PP).
Sterile and disposable.
Sterilization method: ethylene oxide.
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.
Packaging and labelling:
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 IIa device
Safety & product Standards:
Must comply with the following standards:
ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 11607-1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN 20594-1:1994, ISO 594-1:1986
EN ISO 7886-1:1997
Product and packaging complies with WHO PQS E08.
Environmental requirements:
Polymer not PVC
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $6.04 |
