FDA-Device2020-10-21Class II
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock.
Cook Inc.
Hazard
The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation.
Sold states
Worldwide distribution - US Nationwide.
Affected count
380
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0106-2021Don't want to check this manually?
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