IUD Copper TCU 380A

Product details

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.

Storage

Store between 15º and 25º C.

Waste management

Immediately after removal, dispose of the device into a sharps container.

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.