Stapler Reload - India CDSCO Medical Device Registration

Stapler Reload is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000274_5b85b8cf35758ed7ab3116112792d124_08bf8b9ec97e59f970be8b517fbd3f08. This device is marketed under the brand name EndoWrist® Stapler 30 Reload; EndoWrist® Stapler 45 Reload; . 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 C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Stapler Reload

UID: IMP/MD/2020/000274_5b85b8cf35758ed7ab3116112792d124_08bf8b9ec97e59f970be8b517fbd3f08

Brand Name

EndoWrist® Stapler 30 Reload; EndoWrist® Stapler 45 Reload;

License Holder

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

Device Class

Class C

Approving Authority

CDSCO

Product Information

Stapler Reloads are intended to be used with the da Vinci Xi and X Surgical Systems (EndoWrist® Stapler 30 Reload; EndoWrist® Stapler 45 Reload; ) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (EndoWrist® Stapler 30 Reload; EndoWrist® Stapler 45 Reload; ).

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Stapler Reload

Brand: SureForm® 45 Reload

Class C

Stapler Reload

Brand: SureForm® 45 Reload

Intuitive Surgical India Pvt. Ltd

Class C

Stapler Reload

Brand: EndoWrist® Stapler 30 Reload; EndoWrist® Stapler 45 Reload;

Class C

Other Products from 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

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