Product description:
For injection and various other uses, including mixing.
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.
Syringe, two pieces: barrel with Luer nozzle and plunger of three pieces barrel with luer nozzle plunger and piston.
Barrel:
- With finger grip.
- Materials: medical grade PE (polyethylene) of PP (polypropylene);
- transparent for easy reading and for detecting air bubbles.
- Cylindrical shape.
- Graduation scale: clear, water resistant, with scale interval of 0.01 ml ( 3-pieces syringe) of 0.05 ml ( 2 -piece syringe)
- Ends in a male Luer tip (conical with 6% taper).
- The Luer nozzle shall be situated centrally.
Plunger:
- Material: PP (polypropylene)
- Slides inside the barrel.
Gasket:
- Material: elastomer, medical grade.
- Located at the end of the plunger.
- Ensures a secure and safe seal
Capacity: 1 ml
Sterile, single use
Sterilisation method: Ethylene oxide.
Instructions for use:
For injection and various other uses, including mixing.
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.
Accessories/ spare parts/consumables:
- syringe needle
Packaging and labelling:
Primary packaging:
-One (1) syringe packed in an individual sterilised peel-pack made of paper and/of plastic.
Labelling on the primary packaging:
- Name and/of trade mark, and address of f the manufacturer.
- Manufacturer's product reference.
- Type of product and main characteristics.
- 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 by year and month, prefixed by the word "EXP" (of equivalent harmonised symbol).
- The words "of single use" (of equivalent harmonised symbol).
- The words "check the integrity of the individual sterilised pack before use" (of equivalent harmonised symbol).
Symbols used according ISO 15223 and EN 980
CE mark and Notified Body number
Secondary packaging: Protected unit.
1 box of 100 blister packed syringes.
Secondary packaging:
- Protected unit, one (1) box 100-unit presentation;
- labelling is the same as that of the primary packaging. Number of units per secondary packaging, information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.).
Symbols used according ISO 15223 and EN 980
CE mark 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
Environmental requirements:
Not use PVC polymer
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $3.80 |
