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INTRA UTERINE DEVICE, (I.U.D.), copper, TCU 380 A

https://unicat.msf.org/cat/product/19047
STD SMSUIUDE1C-

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Former Code(s): -X
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
22.1.3 - Intrauterine devices
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
U110201 - Intrauterine coils
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
III
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
CT30
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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INTRA UTERINE DEVICE, (I.U.D.)

Definition

Intra-uterine contraceptive with localised action.

Small T-shaped flexible plastic device, with 2 copper strings (reinforcing the contraceptive effect) placed at the fundus of the uterus to prevent fertilization.

Specifications

Quality standards

ISO 7439, 2015, edition 3, Copper-bearing intra-uterine contraceptive devices - Requirements, tests

Technical specifications

  • T-shaped IUD (polyethylene)
    • Vertical axis of the "T":
      • length: 35.69 to 36.20 mm
      • diameter: 1.57 ± 0.05 mm
    • Horizontal axis of the "T":
      • length: 31.50 to 32.13 mm
      • diameter: 1.57 ± 0.05 mm
      • tip diameter: 2.93 to 3.07 mm
  • Copper wiring
    • Minimum 380 mm2 wire in total:
      • 314 mm2 wrapped around the vertical axis
      • 33 mm2 on each transversal arm
    • Purity of copper wire: 99.99 % minimum
    • Weight of copper: 180 ± 10 mg
  • Two white strings, attached to the base of the IUD
    • length: 10,5 to 12.5 cm
  • Insertion tube (high density polyethylene - HDPE)
    • Length: 206 ± 3 mm
    • Internal diameter: 3.734 ± 0.1 mm
    • External diameter: 4.394 ± 0.1 mm
    • Fitted with a sliding blue collar
  • Plunger (ABS)
    • Solid, white and opaque tube, terminating in a loop at one end
    • Length: 188 to 193 mm
    • Diameter at extremity: 2.67 to 2.90 mm
  • Setting guide (cardboard): graduated in cm, from 0 to 11 cm
  • X-ray visible device
  • Sterile, for single use

Packaging & Labelling

Each IUD is packed in a disposable peel pack allowing effective sterilization, safe handling, and storage until needed for use and facilitating proper aseptic presentation.

Instructions for use

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Storage

Store between 15º and 25º C.

Waste management

Immediately after removal, dispose of the device into a sharps container (see related articles below).

MSF requirements

The copper wire surface determines the IUD effectiveness and period of use. It must be of minimum 380 mm².

The TCu 380A provides long duration contraceptive protection (for up to 10 years).

The TCu 380A is intended for uterine cavity depth between 6 and 9 cm.

According to a UNFPA study, the effectiveness of Tcu380A is double compared to that of the Multiload 375®.

NB The shorter intra-uterine devices available on the market (length of the vertical axis of the "T" = 30 mm) are reserved for nulliparae (uterine cavity depth: 5 to 8 cm).

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