CE Marked medical device in applicable markets (according to manufacturer and distributor documentation).
Designed and tested in accordance with ISO 7864 for sterile hypodermic needles where stated by manufacturer.
Needle tubing manufactured to meet ISO 9626 requirements for stainless steel needle tubing for the manufacture of medical devices where specified.
CE Marked medical device in applicable markets (according to manufacturer and distributor documentation).
Designed and tested in accordance with ISO 7864 for sterile hypodermic needles where stated by manufacturer.
Needle tubing manufactured to meet ISO 9626 requirements for stainless steel needle tubing for the manufacture of medical devices where specified.
Colour coding of needle hubs in accordance with ISO 6009 for identification of needle gauges (21G = green).
Luer connection in accordance with ISO 80369 7 compatibility requirements for small Bore connectors where applicable.
Description
Hypodermic Sol-M Needle 21G x 1 1/2\ is a sterile, single-use standard hypodermic needle from the Sol-M product line, featuring a triple-bevel lubricated stainless steel bevel to minimise patient discomfort. The 21-gauge, 1.5 inch (38 mm) needle is fitted with a colour-coded, translucent hub for easy gauge identification and flashback confirmation, and is compatible with all standard Luer Lock and Luer Slip syringes. Supplied as a box of 100 individually wrapped needles.
Bnefits
Triple-bevel lubricated stainless steel bevel minimises penetration force and patient discomfort during injections.
Colour-coded hubs in accordance with ISO 6009 allow easy and rapid identification of needle gauge (21G = green).
Translucent hubs support visual flashback confirmation to help verify intravascular placement when required.
Compatible with all standard Luer Lock and Luer Slip syringes, providing flexibility across clinical settings.
Sterile, single-use construction reduces risk of cross-contamination and infection.
Extra needle sharpness improves ease of skin penetration and can enhance patient comfort.
Blister peel-apart packaging allows easy, aseptic removal of the needle from its pack.
Wide range product line ensures consistent handling characteristics across multiple gauges and lengths for different procedures.
Indications
Used to withdraw blood or other body fluids from the body.
Used to inject medications or other fluids into the body.
Suitable for intramuscular injections where a 21G x 1.5" needle length and gauge are clinically appropriate.
Suitable for intravenous or intra-arterial injections when indicated and when a 21G x 1.5" needle is appropriate.
General-purpose hypodermic use in hospital, clinic and ambulatory care settings by licensed healthcare professionals.
Composition
Standard single-lumen hypodermic needle manufactured from medical-grade stainless steel.
Colour coding of needle hubs in accordance with ISO 6009 for identification of needle gauges (21G = green).
Luer connection in accordance with ISO 80369 7 compatibility requirements for small Bore connectors where applicable.
Manufactured under an ISO 13485 Certified quality management system (Sol Millennium Medical Group).
Manufactured under an ISO 13485 Certified quality management system (Sol Millennium Medical Group).
Standard hypodermic needles
Triple-bevel needle tip with special surface lubrication to reduce insertion force.
Translucent, colour-coded hub (green for 21G) manufactured from polypropylene or equivalent medical-grade polymer.
Luer-type hub compatible with standard Luer Lock and Luer Slip syringe connectors.
Sterile, single-use device not intended to be reprocessed or re-sterilised.
Formulation
Medical device: sterile, single-use hypodermic needle without integrated syringe.
Gauge: 21G (green hub) with regular bevel needle tip.
Needle length: 1.5 inch (38.1 mm).
Hub connection: Luer Lock and Luer Slip compatible.
Pack size: 100 needles per box (some cases supplied as 10 boxes of 100).
Packaging
Box of 100 Sol-M hypodermic needles (21G x 1.5").
Each needle is individually packaged in a sterile blister pack or peel-apart pack.
Outer carton and labelling indicate gauge, length, lot number and expiry date.
Colour-coded labelling (green) in line with needle gauge for quick identification.
Usage
Inspect packaging before use; do not use if the blister or peel-apart pack is damaged, opened or past the expiry date.
Using aseptic technique, open the individual pack and remove the needle without contaminating the tip.
Firmly attach the needle hub to a compatible Luer Lock or Luer Slip syringe, ensuring a secure connection.
Prepare medication and the injection site according to local clinical guidelines and the medication’s prescribing information.
Perform venipuncture or injection (intramuscular, subcutaneous, intravenous, intra-arterial) using appropriate technique for the selected route and needle size.
After use, do not recap, bend or manually detach the needle from the syringe; handle as a contaminated sharp.
Immediately dispose of the used needle and syringe together in an approved sharps container.
Device is intended for single use only; do not reuse or attempt to re-sterilise.
Contraindications
Do not use if sterile packaging is damaged, opened or compromised.
Do not reuse or re-sterilise; reuse may lead to infection, needlestick injury or device malfunction.
Not to be used by untrained personnel; intended for licensed healthcare professionals familiar with injection and phlebotomy techniques.
Avoid use in patients with known hypersensitivity to any component of the device if such sensitivity is suspected.
Do not use for procedures where an alternative needle size, length or device type is specifically required (e.g. specialised spinal or biopsy needles).
Adverse Effects
Local pain, discomfort or bruising at the injection or puncture site.
Minor bleeding or haematoma formation at the puncture site.
Infection at the injection site if aseptic technique or infection prevention measures are inadequate.
Potential tissue, nerve or vascular injury if injection site selection or technique is inappropriate.
Risk of accidental needlestick injury to healthcare workers or others if sharps safety procedures are not followed.
Storage Conditions
Store in a clean, dry environment at room temperature within the range specified on the packaging.
Keep away from direct sunlight, excessive heat, moisture and corrosive or contaminating chemicals.
Store in original packaging until immediately prior to use to maintain sterility.
Do not use after the expiry date printed on the packaging.
Protect from mechanical stress, crushing or bending during storage and transport.
Duration
Not applicable (device is used once per injection or blood draw; overall treatment duration depends on the prescribed therapy).
Onset
Not applicable (onset of effect is determined by the medication administered and route of administration, not by the needle itself).
