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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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TraumaGuard Intra-abdominal Pressure-Sensing System - 00860003478707

TraumaGuard Intra-abdominal Pressure-Sensing Catheter (“TG”). TG is a urine drainage catheter that provides continuous biometric monitoring of Intra-abdominal Pressure (“IAP”) and Core Body Temperature (CBT). TG is a silicone catheter with polyurethane sensing balloons. IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The TraumaGuard Intra-abdominal Pressure-Sensing System Catheter is a single-use device intended for short-term use (less than 30 days).
SENTINEL MEDICAL TECHNOLOGIES
TraumaGuard Intra-abdominal Pressure-Sensing System Single Catheter
In Commercial Distribution

  • 00860003478707 ()
000-0219

  • Multi-parameter urinary monitoring system catheter set

ClarifEye - 00884838104570

Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy.
Philips Medical Systems Nederland B.V.
ClarifEye - 1
In Commercial Distribution

  • 00884838104570 ()
002120

  • Stereotactic system application software

10001 PercuNav Patient Tracker - 00884838068643

No Description
Philips Ultrasound LLC
989605427133
In Commercial Distribution

  • 00884838068643 ()


  • Multi-purpose stereotactic surgery system

21001 PercuNav Endocavity Ultrasound Tracker - 00884838068636

No Description
Philips Ultrasound LLC
989605435122
In Commercial Distribution

  • 00884838068636 ()


  • Multi-purpose stereotactic surgery system

20004 PercuNav Ultrasound Tracker - 00884838068629

No Description
Philips Ultrasound LLC
989605428083
In Commercial Distribution

  • 00884838068629 ()


  • Multi-purpose stereotactic surgery system

41001 PercuNav Adaptive Needle Tracker - 00884838068605

No Description
Philips Ultrasound LLC
989605428073
In Commercial Distribution

  • 00884838068605 ()


  • Multi-purpose stereotactic surgery system

ARTIS icono ceiling - 04056869295923

No Description
Siemens Healthcare GmbH
11328100
In Commercial Distribution

  • 04056869295923 ()


  • Stationary angiographic x-ray system, digital

ARTIS icono floor - 04056869149325

No Description
Siemens Healthcare GmbH
11327700
In Commercial Distribution

  • 04056869149325 ()


  • Stationary angiographic x-ray system, digital

ARTIS icono biplane - 04056869063317

No Description
Siemens Healthcare GmbH
11327600
In Commercial Distribution

  • 04056869063317 ()


  • Stationary angiographic x-ray system, digital

Artis zee biplane MN - 04056869010106

No Description
Siemens Healthcare GmbH
10094143
In Commercial Distribution

  • 04056869010106 ()


  • Stationary angiographic x-ray system, digital
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