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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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Xenon light source 300 Watts, US Power Cord - Storz adapter
SOPRO
SOPRO 230 - SOURCE DE LUMIERE XENON 300W - SOPRO
In Commercial Distribution

  • M430S23000051 ()
S_230_0005

  • Endoscopic light source unit, line-powered
Xenon light source 180 Watts, US Power Cord - Wolf adapter
SOPRO
S218 SOPRO US WOLF
In Commercial Distribution

  • M430S21800121 ()
S_218_0012

  • Endoscopic light source unit, line-powered
Xenon light source 180 Watts, US Power Cord - Olympus adapter
SOPRO
S218 SOPRO US OLYMPUS
In Commercial Distribution

  • M430S21800111 ()
S_218_0011

  • Endoscopic light source unit, line-powered
Xenon light source 180 Watts, US Power Cord - Olympus adapter
SOPRO
S218 SOPRO US OLYMPUS
In Commercial Distribution

  • M430S21800091 ()
S_218_0009

  • Endoscopic light source unit, line-powered
Xenon light source 180 Watts, US Power Cord - Storz adapter
SOPRO
SOPRO 218 - SOURCE DE LUMIERE XENON 180W - SOPRO - US
In Commercial Distribution

  • M430S21800061 ()
S_218_0006

  • Endoscopic light source unit, line-powered
ThermaGard Electronically Controlled Nebulizer Heater For Use with HUDSON RCI REF 1770 Variable Concentration Large Volume Nebulizer
TELEFLEX INCORPORATED
IPN914467
In Commercial Distribution

  • 14026704663887 ()
  • 24026704663884 ()

  • Length: 4 Inch
  • Height: 4.5 Inch
5705

  • Benchtop nebulizer, heated
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
No Description
Therabody, Inc.
RecoveryTherm Hot/Cold/Vibration Knee
In Commercial Distribution

  • 00810036059732 ()


  • Hand-held electric massager
  • Electric pad localized-body heating system
  • Hot/cold therapy pack, reusable
No Description
W.O.M. World of Medicine GmbH
INSFHTDTUB
In Commercial Distribution

  • 04056702008789 ()
  • 04056702008772 ()


  • Endoscopic insufflation tubing set, single-use
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