Ureteral Stent - India CDSCO Medical Device Registration

Ureteral Stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000292_e0e7f84fa336a7ce49c5b4279b636370_be74595ee6e7f3168a691dc324070787. This device is marketed under the brand name Bard Fluoro 4 Silicone Ureteral stent, Bard Fluoro-4 Silicone Ureteral coil stent. The license holder is Becton Dickinson India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Ureteral Stent

UID: IMP/MD/2022/000292_e0e7f84fa336a7ce49c5b4279b636370_be74595ee6e7f3168a691dc324070787

Brand Name

Bard Fluoro 4 Silicone Ureteral stent, Bard Fluoro-4 Silicone Ureteral coil stent

License Holder

Becton Dickinson India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Indicated to relieve obstruction in a variety of benign, malignant and posttraumatic conditions in the ureter. These conditions include stones and / or stone fragments, or other Ureteral obstructions such as those associated with Ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or Ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (Bard Fluoro 4 Silicone Ureteral stent, Bard Fluoro-4 Silicone Ureteral coil stent). The sent may be placed using endoscopic surgical techniques or percutaneouly using standard radiographic technique. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device