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K-Pack Surshield™ - Needles with passive sharps protection

Dedicated to the pharmaceutical industry, K-Pack Surshield™ is an innovative hypodermic needle with an integrated passive sharps protection feature for use with (pre)-filled syringes.

The device geometry is designed to allow for automated manipulations during the packaging process, making it ideal for bundling and inclusion into the secondary packaging of parenteral medication.

Characteristics

User criteria and benefits:

  • Truly passive system; easy to use sharps protection
  • Efficient and permanent cover of the sharps
  • Not possible to skip a crucial step to activate
  • Needle sharps not exposed, before, during and after injection
  • Does not require more time to use
  • Clear view of syringe contents and access to syringe label
  • Permanent and visual indication of activation
  • Ergonomics appropriate for injection technique
  • Terumo needle designed for patient comfort

 

Manufacturing perspective:

  • Compact design, individually packed, requiring minimal space
  • Product configuration suited for automated manipulations
  • Colour coding on tamper-evident label, for in-line product detection by vision systems
  • Does not require an additional assembly step (less investment compared to add-on systems)
  • Less involvement of Pharma for product and process validation
    (time-to-market)
  • Own regulatory status as a medical device (time-to-market)
  • Safety feature activation does not require interaction with the syringe; does not affect the syringe performance (e.g. dose accuracy)
  • Provided by a global operating company with core competences in needle manufacturing​

General Specifications

K-Pack Surshield™ is intended for subcutaneous and intra-muscular applications.

Needle PointLancet point (3-bevel)
CannulaeStainless steel X5CrNi 18-10
HubPolypropylene
Conical fittingISO 594-1 (EN 20594-1) / ISO 594-2 (EN 1707)
Individual packagingRigid packaging with tamper-evident label
Method of sterilizationEthylene Oxide
Shelf Life5 years

The device has no components made of natural rubber latex.
The device has no components made of PVC/DEHP.

K-Pack Surshield™ fulfils the requirements of:

  • EN ISO 7864 - Sterile hypodermic needles for single use
  • ISO 23908 - Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

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Item Specifications

Reference codeColour code

External diameter of the cannulae

Gauge (G) mm

Needle length (mm)
KN-S2516RBSalmon250.516
KN-S2713RBGrey270.412

Please note that some products may not be available in your country. Please contact Terumo Europe NV for more information.

 

 

 

 

 

 

 

 

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