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Pack Pacemaker NL1


BRIEF DESCRIPTION

Custom procedure pack for permanent pacemaker placement

PRODUCT CODE

05-117641AΒ-03

COUNTRY OF ORIGIN

The Netherlands

TRADE NAME

PACK PACEMAKER NL1

APPROVAL BY THE NATIONAL ORGANIZATION FOR MEDICINES (NOM)

2820008839529

PACK PACEMAKER NL1 is a complete, high quality interventional cardiology procedure pack designed to meet the needs of the pacemaker placement procedure.

It is a ready to use solution that includes all essential medical consumables for pacemaker placement procedures, contributing to reduced preparation time while maintaining full sterility throughout the process.

It is manufactured using high quality materials, sourced only from certified suppliers in the USA, the United Kingdom, and Europe. Final assembly and packaging take place in the Netherlands by Medica Europe B.V., in compliance with strict quality standards and the European Regulation EU 2017/745 (MDR).


Package Contents

PACK PACEMAKER NL1 is a complete pacemaker placement set that includes the following components:

S/N

DESCRIPTION

UNIT

1

DRAPE PACEM 3PLY for permanent pacemaker with square opening 12 Χ 12cm and transparent along both sides 360 x 260cm, Blue

1

2

Transparent protective cover 102Χ50cm, round

1

3

Transparent protective cover 91Χ104cm, square

1

4

Surgical Table Cover 195Χ150cm, (waterproof, lined, absorbent), Blue

1

5

Medical gown size: XL lined and hypoallergenic

1

6

Hand towel 42.5 X 30.5cm

1

7

10x10cm Gauze, 12ply, X-ray

20

8

Round Bowl 500ml, Blue

3

9

Needle 16G X 4cm

1

10

Syringe 2ml, luer slip

1

11

Syringe 20ml, luer slip

2

12

Scalpel #21 with 13cm plastic handle

1

13

Special sponge with plastic handle 19cm, for Betadine of foerster clamp type

1

 

Key Benefits

  • CE MDR Compliance: Class IIa medical device in accordance with EU Regulation 2017/745
  • Complete set: All necessary components in a single, integrated package
  • Reduced preparation time: Ready to use solution for faster and more efficient setup
  • Consistent high quality: Carefully selected consumables from internationally certified suppliers
  • Optimized logistics: Simplifies inventory and procurement management
  • Full traceability: LOT and Reference Number indicated on each package

Certifications & Packaging

The product is supplied:

  • Sterile
  • Single-use

and complies with the following standards:

  • ISO 13485:2016
  • EN ISO 13485:2016
  • CE marking in accordance with EU Regulation 2017/745 (MDR)
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