Insertion Pack - India CDSCO Medical Device Registration
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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Brand Name
Sonablate
License Holder
NovoMed Incorporation Pvt. Ltd.Device Class
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 patientโs tissue for imaging and ablating said tissue, by circulating water as a couplant that is degassed and is temperature controlled.
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