Insufflator System
- UID
- IMP/MD/2019/000431_766f84e9bdae287490c2503c65849c36_ea04434d9b5d450713cd192762a0c2df
- Device class
- Class B
- Brand name
- AirSeal® iFS System
- License holder
- M/s Linvatec India Private Limited
- Approving authority
- CDSCO
- Product information
- The SurgiQuestAirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. It is indicated to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument is used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.
Insufflator System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000431_766f84e9bdae287490c2503c65849c36_ea04434d9b5d450713cd192762a0c2df. This device is marketed under the brand name AirSeal® iFS System. The license holder is M/s Linvatec India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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