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MESBIO NEEDLE 34G 12mm Box of 100

MESBIO NEEDLE 34G 12mm Box of 100

Mesbio Needle

Needles & Cannulas
  • CE 0459 marked medical device (Class IIa).
  • Manufactured under ISO 13485:2016 certified quality management system.
Mesotherapy hypodermic needle

Description

MESBIO NEEDLE 34G 12mm (0.20 x 12 mm) is an ultra-fine hypodermic needle specifically developed by Needle Concept for mesotherapy, botulinum toxin injections and other superficial intradermal or hypodermic applications. Manufactured 100% in France, Mesbio needles are part of the Mesbio®Needle range and are known for their high precision, patient comfort and very thin wall (ETW / ultra-thin wall in some references). Each 34G needle is mounted on a colour-coded Luer Lock hub in accordance with ISO standards, supplied sterile and single use. Needles are individually blister packed, with 100 needles per box. The device is CE 0459 marked, produced under an ISO 13485:2016 certified quality management system and classified as a Class IIa medical device.

Bnefits

  • Ultra-fine 34G (0.20 mm) needle diameter designed to minimise patient discomfort during micro-injections.
  • 12 mm length optimised for superficial intradermal and hypodermic injections used in mesotherapy and aesthetic procedures.
  • 100% manufactured in France by Needle Concept, ensuring traceability and consistent quality.
  • Colour-coded Luer Lock hubs in line with ISO standards for easy gauge identification and secure connection to syringes.
  • Sterile, single-use hypodermic needles reduce infection risk and support best practice in injection safety.
  • ETW (extra thin wall / ultra-thin wall) design on Mesbio range improves flow characteristics and helps reduce injection force.
  • High-precision needle bevel and surgical-grade steel construction support accurate placement and smooth tissue penetration.
  • Individually blister packed needles maintain sterility until point of use and simplify handling in clinical settings.
  • CE 0459 marked and manufactured under ISO 13485:2016, Class IIa medical device requirements, providing regulatory assurance for clinical use.

Indications

  • Designed for mesotherapy injections (superficial intradermal delivery of small volumes over multiple micro-injection points).
  • Suitable for botulinum toxin injections where a 34G 12 mm needle is clinically appropriate.
  • Indicated for other intradermal or superficial hypodermic aesthetic procedures such as skin boosters, fine-line treatments and certain periocular or facial micro-injections, according to local practice and product labelling.
  • Use only by trained and appropriately licensed healthcare professionals familiar with injection techniques and relevant medicinal products.
  • Not intended for high-volume injections, deep intramuscular injections or procedures requiring larger bore needles.

Composition

  • Needle: surgical-grade stainless steel hypodermic tubing, ultra-thin wall (ETW) for improved flow and reduced injection force.
  • Bevel: high-precision ground bevel designed for micro-injections and reduced insertion trauma.
  • Gauge and length: 34G, 0.20 x 12 mm.
  • Hub: Luer Lock plastic hub, colour coded in accordance with ISO standards for gauge identification.
  • Packaging: needles supplied individually in sterile blister packs housed in an outer cardboard box of 100.
  • Sterility: ethylene oxide sterilised (typical for this device category; single use only).

Formulation

  • Medical device type: sterile, single-use hypodermic needle for intradermal and hypodermic injections.
  • Mesbio®Needle concept: ultra-fine gauge and thin-walled steel tube to combine precision, reduced patient pain and optimised product flow.
  • Mechanical design: Luer Lock hub for secure, leak-free connection with standard Luer Lock syringes.
  • Regulatory formulation: CE 0459 Class IIa medical device, manufactured under ISO 13485:2016-compliant quality management system.
  • Product concept: wide range of gauges (27G–34G) and lengths (4–25 mm) within the Mesbio family, with this reference representing the 34G x 12 mm configuration.

Packaging

  • Box of 100 MESBIO 34G x 12 mm needles.
  • Each needle is individually packed in a sterile blister with Luer Lock hub protected.
  • Blister packs supplied in a labelled outer carton detailing product name, gauge, length, lot number, expiry date, CE mark (0459) and manufacturer information.
  • Hubs are colour-coded according to ISO standards and visible through the primary packaging for easy identification.
  • Outer packaging designed to protect the contents from physical damage, dust and environmental contamination during transport and storage.

Usage

  • Use only by trained and appropriately licensed healthcare professionals familiar with mesotherapy and other injection techniques.
  • Verify the integrity of the sterile blister packaging and check expiry date before use; do not use if the blister is damaged or opened.
  • Open the blister aseptically, grasp the Luer Lock hub and attach the needle securely to a compatible Luer Lock syringe, avoiding contact with the needle tip.
  • Prime the needle in accordance with the medicinal product’s instructions, ensuring there is no air in the system as per local protocols.
  • Perform injections according to the technique, depth and dosing schedule appropriate for the medicinal product and indication (e.g. mesotherapy, botulinum toxin), following all relevant clinical guidelines and product summaries of product characteristics (SmPCs).
  • After use, do not recap the needle; immediately dispose of the used needle and syringe assembly into an approved sharps container in line with local sharps safety policies.
  • Single use only: do not attempt to re-use, re-sharpen or re-sterilise MESBIO needles.

Contraindications

  • Do not use in patients with known hypersensitivity or allergy to stainless steel or any other component of the needle.
  • Contraindicated where intradermal or hypodermic injection is not appropriate for the patient or indication.
  • Do not use if the sterile packaging is damaged, opened or past the indicated expiry date.
  • Not suitable for re-use, re-sterilisation or for use with non-Luer Lock syringe systems.
  • Use of 34G ultra-fine needles may be inappropriate for high-viscosity products or high-volume injections where larger gauge needles are recommended.

Adverse Effects

  • Local injection-related reactions such as pain, erythema, bruising, bleeding, swelling or haematoma at the injection site may occur, largely related to the injection procedure rather than the needle itself.
  • Rare risk of needle breakage or bending if improperly handled or used with excessive force.
  • Potential for needlestick injury to the practitioner or staff if standard sharps precautions are not followed.
  • Hypersensitivity reactions in individuals allergic to stainless steel or trace metals in the alloy, although uncommon.
  • Infections at the injection site may occur if aseptic technique is not observed, if the skin is not adequately disinfected or if a non-sterile needle is used.

Storage Conditions

  • Store in a clean, dry place at room temperature, away from direct sunlight and sources of excessive heat or moisture.
  • Keep needles in their original packaging until immediately before use to maintain sterility and protect from contamination.
  • Avoid crushing, bending or otherwise damaging the blister packs or outer carton during storage and handling.
  • Do not freeze or expose to extreme temperatures that could compromise packaging integrity.
  • Observe and respect the expiry date printed on the packaging; do not use expired product.

Duration

Not applicable to the device itself; duration and frequency of treatment depend on the medicinal product being injected and the clinical protocol used.

Onset

Not applicable to the needle; onset of effect is determined by the injected product and the clinical indication.

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