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Dissolvable Gel For Preventing Ureteral Stone Migration

FDA product code ONJ · 1 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.4680
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-06-02 – 2009-06-02

For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.

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