Sphincterotome
- UID
- IMP/MD/2018/000084_93ac37c9a3583d26510672366cc66a10_2da3895f1fff15081571f6513af193ed
- Device class
- Class C
- Brand name
- NeedleCut 3V
- License holder
- Olympus Medical System India Pvt. Ltd
- Approving authority
- CDSCO
- Product information
- Single Use 3-Lumen Sphincterotome V - These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Single Use Sphincterotome V (NeedleCut 3V) - These instruments (NeedleCut 3V) have been designed to be used with an Olympus endoscope for papillotomy using high-frequency current. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts
Sphincterotome is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000084_93ac37c9a3583d26510672366cc66a10_2da3895f1fff15081571f6513af193ed. This device is marketed under the brand name NeedleCut 3V. The license holder is Olympus Medical System India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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