paragard t 380a - Medication Listings

Figure 10 Figure 11 11.1 Paragard IUS Paragard (intrauterine copper contraceptive) is a T-shaped intrauterine system (IUS), measuring 32 mm horizontally and 36 mm vertically, with a 3 mm diameter bulb at the tip of the vertical stem. (See Figure 10) [see Dosage and Administration (2.3)]. A monofilament polyethylene thread is tied through the tip, resulting in two white threads, each approximately 36.5 cm in length, to aid in detection and removal of the intrauterine system. The T-frame is made of polyethylene with barium sulfate to aid in detecting the intrauterine system under x-ray. Paragard also contains copper (approximately 176 mg of wire wrapped around the vertical stem and an approximately 68.7 mg collar placed on each side of the horizontal arm). The total exposed copper surface area is 380 ± 23 mm². One Paragard weighs less than one (1) gram. Figure 10 – Paragard IUS Paragard, its components, and the packaging are not made with natural rubber latex. 11.2 Inserter Paragard is packaged with a sterile pre-assembled inserter as a single-use, disposable device in a tray and in a Tyvek ® polyethylene pouch. A moveable blue flange on the insertion tube aids in gauging the depth of insertion through the cervical canal and into the uterine cavity (See Figure 11) [see Dosage and Administration ( 2.3 )]. Figure 11 – Paragard with Inserter

Paragard (intrauterine copper contraceptive) is a T-shaped intrauterine system (IUS), measuring 32 mm horizontally and 36 mm vertically, with a 3 mm diameter bulb at the tip of the vertical stem. (See Figure 1) [see Dosage and Administration ( 2.3 )]. A monofilament polyethylene thread is tied through the tip, resulting in two white threads, each at least 10.5 cm in length, to aid in detection and removal of the intrauterine system. The T-frame is made of polyethylene with barium sulfate to aid in detecting the intrauterine system under x-ray. Paragard also contains copper (approximately 176 mg of wire wrapped around the vertical stem and an approximately 68.7 mg collar placed on each side of the horizontal arm). The total exposed copper surface area is 380 ± 23 mm². One Paragard weighs less than one (1) gram. Paragard and its components are not made with natural rubber latex. Paragard is packaged together with an insertion tube and solid white rod in a Tyvek® polyethylene pouch that is then sterilized. A moveable blue flange on the insertion tube aids in gauging the depth of insertion through the cervical canal and into the uterine cavity (See Figure 1) [see Dosage and Administration ( 2.3 )].