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Used in fetal urinary tract decompression following the diagnosis of fetal postvesicular obstructive uropathy in fetuses of 18 to 32 weeks gestational age.
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Wire Guide Length cm
Multi-length Stent Fr
EchoTip® Trocar Needle (13 gage stainless steel 18 cm long)
Straight Safety Wire Guide (.038 inch [0.97 mm] diameter PTFE coated stainless steel 40 cm long)
Stent Positioner (5 Fr radiolucent vinyl 24 cm long)
Multi-Length Stent (5 Fr Sof-Flex® 1.5 to 3.5 cm long)
HUMANITARIAN DEVICE: Authorized by federal (U.S.A.) law for use in the treatment of fetal post-vesicular obstructive uropathy. The effectiveness of this device for this use has not been demonstrated.
CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a physician with appropriate training and experience.