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CDSCO UID IMP/MD/2023/000741_7a77592dbb87aa124e60f06cd9ecab45_df236cc2500cec50bd062ddc1286c287

Insertion Pack

NovoMed Incorporation Pvt. Ltd.·Device Class Class B·India CDSCO·Brand: Sonablate
Registration details
UID
IMP/MD/2023/000741_7a77592dbb87aa124e60f06cd9ecab45_df236cc2500cec50bd062ddc1286c287
Device class
Class B
Brand name
Sonablate
License holder
NovoMed Incorporation Pvt. Ltd.
Approving authority
CDSCO
Product information
The Sonablate Insertion Pack is intended to be used with the Sonablate System. The Sonablate Probe Tip Kit contains components to cover the tip of the Sonablate Probe, to create a contained bolus of water that acts as the transrectal interface to the patient. The intended use of the Water Path Kit is to provide a means of coupling ultrasonic energy from a transducer into a patient’s tissue for imaging and ablating said tissue, by circulating water as a couplant that is degassed and is temperature controlled.
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About this record

Insertion Pack is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000741_7a77592dbb87aa124e60f06cd9ecab45_df236cc2500cec50bd062ddc1286c287. This device is marketed under the brand name Sonablate. The license holder is NovoMed Incorporation Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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