Used in fetal urinary tract decompression following the diagnosis of fetal postvesicular obstructive uropathy in fetuses of 18 to 32 weeks gestational age.
Instructions for Use (IFUs) linked below are the most current version associated with the product. To find an IFU associated with a specific Lot Number, please visit https://ifu.cookmedical.com/.
Order Number | Reference Part Number |
Instructions for Use (IFU) |
MR Status |
Guide Needle gage |
Guide Needle Length cm |
Wire Guide Diameter inch/mm |
More Info |
---|---|---|---|---|---|---|---|
G16766 | J-HFBS-503540 |
|
N/A | 13 | 18 | .038/.97 | Expand » |
Additional Specs
Description
-
Wire Guide Length cm
40
Multi-length Stent Fr/Diameter cm
5.0/1.5-3.5
Included Components
Description
Quantity
EchoTip® Trocar Needle (13 gage stainless steel 18 cm long)
1
Straight Safety Wire Guide (.038 inch [0.97 mm] diameter PTFE coated stainless steel 40 cm long)
1
Stent Positioner (5 Fr radiolucent vinyl 24 cm long)
1
Multi-Length Stent (5 Fr Sof-Flex® 1.5 to 3.5 cm long)
1
|
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.
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Information provided on this site is not intended to be professional medical advice. Product Instructions for Use (IFU) should be consulted before use of any product.