Accessory Kits - India CDSCO Medical Device Registration
Accessory Kits is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000102_9c272c5bfe71bbf22a98f558b09fc07b_a89eac9148ee3b271c3d2ddf54a3b272. This device is marketed under the brand name Drapes. The license holder is Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India, and it is classified as Device Class Class A. The approving authority is CDSCO.
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Brand Name
Drapes
Device Class
Approving Authority
CDSCO
Product Information
Robotic equipment drapes are intended as a protective covering for various surgical and/or nonsurgical instruments/equipment to provide and maintain a physical barrier against cross-contamination in various clinical settings. This is a single-use device [not to be reprocessed].
Clip Applier
Brand: SureForm - 45/45 Curved-Tip/60
Suction Irrigator Instrument
Brand: SureForm - 45/45 Curved-Tip/60
Endoscope
Brand: SureForm - 45/45 Curved-Tip/60
Accessory
Brand: 8 mm Endoscope Washer/ Disinfector Connector Set
Accessory
Brand: SureForm - 45/45 Curved-Tip/60
Retractor
Brand: SureForm - 45/45 Curved-Tip/60
Needle Driver Instrument
Brand: SureForm - 45/45 Curved-Tip/60
Obturator(8 mm Bladeless Obturator/ 8mm Bladeless Obturator, Long )
Brand: SureForm - 45/45 Curved-Tip/60
Stapler Instrument
Brand: SureForm - 45/45 Curved-Tip/60
Scissors
Brand: SureForm - 45/45 Curved-Tip/60