Ureteral Stents - India CDSCO Medical Device Registration

Ureteral Stents is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000292_92957a67f46b8047fdc6661c064b9107_c7373f8829f1dac61f2f618b280224ee. 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 Stents

UID: IMP/MD/2022/000292_92957a67f46b8047fdc6661c064b9107_c7373f8829f1dac61f2f618b280224ee

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 such as presence of stones and / or stone fragments, or other Ureteral obstructions such as those associated with Ureteral stricture, carcinoma 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 stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique

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