Manufactured by ASTI Corporation under a medical device quality system; Quatron is listed as a sterile, single Use, non Pyrogenic, non Toxic medical injection needle.
Quatron IFU identifies an EU Representative (Advena Ltd., Malta) and includes Notified Body number 0344, indicating conformity with relevant European medical device regulations.
Needles are precision Made in Japan and are described in distributor materials as produced under ISO 13485 quality control.
Manufactured by ASTI Corporation under a medical device quality system; Quatron is listed as a sterile, single Use, non Pyrogenic, non Toxic medical injection needle.
Quatron IFU identifies an EU Representative (Advena Ltd., Malta) and includes Notified Body number 0344, indicating conformity with relevant European medical device regulations.
Needles are precision Made in Japan and are described in distributor materials as produced under ISO 13485 quality control.
Device classification: single Use sterile needle intended for injection into intradermal, subcutaneous or muscle tissue.
Description
Quatron – Multi Needle, 31G, 10pcs is a sterile, single-use, length-adjustable multi-needle attachment developed by ASTI Corporation for stable and comfortable injectable treatments. The device mounts onto a standard luer-lock syringe and features four very fine 31G (0.26 mm) stainless-steel needle tubes arranged to allow four injections at once with an adjustable penetration depth from 0 to 4 mm. This design enables shallow and broad distribution of injectables into intradermal, subcutaneous, or muscle tissue with less invasiveness, shorter treatment time, reduced downtime, and lower injection force compared with conventional single-needle injections. It is widely used in aesthetic and dermatologic procedures such as dermal filler injections, mesotherapy, PRP, and hair-loss and other skin treatments.
Bnefits
Performs four injections simultaneously, allowing treatment of a broader area in less time.
Adjustable needle length from 0 to 4 mm for precise control of injection depth according to treatment area and indication.
High-quality, very fine 31G needles designed to reduce pain and improve patient comfort.
Perpendicular insertion and length-adjustment mechanism help ensure injections are delivered at the intended depth.
Shallow and broad delivery of injectables for more even product distribution in the tissue.
Less invasive than repeated single-needle punctures, with less downtime and typically less bruising and bleeding.
Reduced injection force due to four exit points, especially helpful with viscous solutions and fibrotic skin.
Sterile, non-pyrogenic, non-toxic and single-use, minimising risk of cross-contamination when used correctly.
Compatible with standard luer-lock syringes, allowing integration into existing injection workflows.
Box of 10 individually packed devices to support multiple treatments under consistent conditions.
Indications
Single-use sterile multi-needle attachment intended for medical injection of fluids into intradermal, subcutaneous, or muscle tissue.
Aesthetic and dermatologic procedures requiring multiple evenly spaced injections, such as mesotherapy.
Dermal filler injections where a shallow and broad distribution of product is desired (in accordance with product instructions and local regulations).
PRP (platelet-rich plasma) and similar regenerative injections into the scalp or skin.
Hair-loss treatments requiring multiple superficial injections across a treatment field.
Local anaesthesia, botulinum toxin treatments for indications such as hyperhidrosis, and steroid injections for conditions like keloids or alopecia areata, where permitted by protocol and regulation.
Composition
Needle tubes: stainless steel (31G, 0.26 mm outer diameter).
Hub (needle hub with female luer-lock connector): polycarbonate.
Length adjuster: polystyrene.
Supplied sterile, non-pyrogenic, non-toxic.
Four fine needles per attachment, arranged for perpendicular multi-point injection.
Product range: Quatron NQ-1 (31G, adjustable up to 4 mm, 10 pcs/box) and NQ-2 (34G, adjustable up to 4 mm, 10 pcs/box).
Packaging
10 Quatron multi-needle attachments (NQ-1, 31G) per box.
Each device supplied sterile in an individual primary package.
Labelling indicates gauge, adjustable length range (0–4 mm), sterility, single-use status, and expiry date.
Outer box identified as QUATRON length-adjustable multi needle with ASTI Corporation manufacturer details and EU representative information.
Usage
Prepare a sterile syringe and a sterile general needle according to institutional protocol.
Attach the sterile general needle to the sterile syringe and draw up the injection fluid in accordance with the relevant product instructions and local procedures.
Remove the general needle from the syringe following its instructions for use; do not use Quatron to draw up fluids from vials or ampoules.
Connect the syringe firmly to the needle hub (female luer-lock connector) of the Quatron device, ensuring a secure, leak-free fit.
Pull the needle cap straight off the Quatron without twisting, taking care not to touch the needle tubes.
Hold the flange of the needle hub and rotate the length adjuster in the direction of the arrow printed on the device until the desired needle length (0–4 mm) is reached; use the adjusting mark as a guide (approximately 1 mm change per full revolution).
Hold the syringe with the needle assembly pointing upwards and check for air bubbles; gently tap and expel visible bubbles according to local protocol.
Insert the four needles perpendicularly to the skin at the planned injection site and inject the fluid according to clinical protocol, keeping the hub stable during injection.
After completing the injection, rotate the length adjuster in the direction of the arrow until it stops and the needle tips are completely covered by the length adjuster; recap if required by local sharps policy.
Immediately discard the used Quatron device as infectious waste in a suitable sharps container following institutional and local regulations; do not attempt to resterilize or reuse.
Use only luer-lock syringes when infusing viscous fluids; using luer-slip syringes may cause detachment during injection.
Select needle gauge and adjusted length appropriate to the treatment area; lengths shorter than approximately 1.5 mm may increase the risk of leakage at the injection site.
Contraindications
Do not resterilize or reuse; Quatron is strictly single-use only. Reuse may increase risk of infection.
Do not use if there is any damage, defacement or abnormality of the primary packaging or the device itself.
Do not use if sterility is compromised or the product is used past the indicated expiry date.
Do not use Quatron to draw up fluids from vials or ampoules, as this may impair or damage the device.
Do not use with syringes other than those compatible with luer-lock connection, especially when injecting viscous solutions.
As with all injection devices, follow general contraindications for injection procedures (e.g. avoid injection into areas with active infection, severe inflammation, or where injection is otherwise contraindicated by the drug product’s prescribing information).
Adverse Effects
Potential risk of infection if sterility is breached or if the device is reused contrary to instructions.
Risk of needle-stick injury if needle tubes are touched during or after cap removal or if disposal is not performed correctly.
Leakage of injection fluid if the length is inadequately set (especially below approximately 1.5 mm) or if insertion is not perpendicular to the skin.
Possible bruising, bleeding, pain or swelling at the injection site, as with other needle-based injection procedures.
Device detachment or leakage if not securely attached to a compatible luer-lock syringe, particularly with viscous fluids.
Any other adverse reactions associated with the injected medicinal product or solution, independent of the device itself.
Storage Conditions
Keep the product in a clean area in its original packaging until use.
Avoid exposure to water, high temperature, high humidity and direct sunlight.
Store in conditions that maintain package integrity and sterility until the indicated expiry date on each individual pack.
Do not use if the packaging is damaged, wet, or otherwise compromised.
Follow any additional storage recommendations on the outer box and local institutional policies for sterile single-use needles.
Duration
Not applicable to the device itself; each Quatron multi needle is intended for single-patient, single-use during a single injection session and must be discarded immediately after use.
Onset
Immediate technical effect upon use: enables simultaneous multi-point injection and broad distribution of injectables during the procedure; any clinical onset of effect depends on the injected product rather than the device.
