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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus. Near-Infrared LED Light Source is intended to be used for providing white light and near-infrared light illumination for optical observation or rear camera system of electronic endoscope during endoscopy and endoscopic surgery, not the illumination provided for the human eye to observe the optical endoscope.The product is composed of a control unit and a power cable, without light guide.
Scivita Medical Technology Co., Ltd.
LSIR330
In Commercial Distribution

  • 06971381250947 ()


  • Endoscopic light source unit, line-powered
The product is composed of a main equipment, a light guide cable and a power cable.The purpose of this product is to provide illumination for optical observation or electronic endoscope rear camera system, not for human eye observation optical endoscope lighting.
Scivita Medical Technology Co., Ltd.
ES-LS110D
In Commercial Distribution

  • 06971381250114 ()


  • Endoscopic light source unit, line-powered
Airlife™ Nebulizer Heater
Carefusion Corporation
2M8021
Not in Commercial Distribution

  • 50885403199132 ()
2M8021

  • Benchtop nebulizer, heated
KIT 300XL HERMES UK
Smith & Nephew, Inc.
7210264
Not in Commercial Distribution

  • 00885554011067 ()
7210264

  • Endoscopic light source unit, line-powered
KIT 300XL U.K.
Smith & Nephew, Inc.
7207414
Not in Commercial Distribution

  • 00885554010145 ()
7207414

  • Endoscopic light source unit, line-powered
MTO KIT 300XL SWEDEN
Smith & Nephew, Inc.
7207412
Not in Commercial Distribution

  • 00885554009712 ()
7207412

  • Endoscopic light source unit, line-powered
SET LAMP ARC
Smith & Nephew, Inc.
2801
Not in Commercial Distribution

  • 00885554002010 ()
2801

  • Endoscopic light source unit, line-powered
MTO KIT 300XL SPAIN
Smith & Nephew, Inc.
7207409
Not in Commercial Distribution

  • 00885554010183 ()
7207409

  • Endoscopic light source unit, line-powered
KIT 300XL ITALY
Smith & Nephew, Inc.
7207411
Not in Commercial Distribution

  • 00885554009071 ()
7207411

  • Endoscopic light source unit, line-powered
MTO KIT XENON INTERNATIONAL
Smith & Nephew, Inc.
7205290
Not in Commercial Distribution

  • 00885556602713 ()
7205290

  • Endoscopic light source unit, line-powered
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