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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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The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermistor plug and temperature port on the Monitor for continuous temperature measurement.
SENTINEL MEDICAL TECHNOLOGIES
TraumaGuard Philips Cable
In Commercial Distribution

  • 00860003478738 ()
000-0250

  • Electrical-only medical device connection cable, reusable
The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermistor plug and temperature port on the Monitor for continuous temperature measurement.
SENTINEL MEDICAL TECHNOLOGIES
TraumaGuard GE Cable
In Commercial Distribution

  • 00860003478721 ()
000-0260

  • Electrical-only medical device connection cable, reusable
The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermistor plug and temperature port on the Monitor for continuous temperature measurement.
SENTINEL MEDICAL TECHNOLOGIES
TraumaGuard Cable Universal
In Commercial Distribution

  • 00860003478714 ()
000-0229

  • Electrical-only medical device connection cable, reusable
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
Red/Infrared LED & Laser Therapy Device for Pain Relief.
MIESSENTIA MEDICAL USA LLC
Painbuster
Not in Commercial Distribution

  • 00860003478103 ()
  • 10860003478100 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
subcortical access sheath 5.2 cm
Minnetronix Neuro, Inc.
5.2cm
In Commercial Distribution

  • 00860003476826 ()

  • Length: 5.2 Centimeter
N-EXP1A-052

  • Neurosurgical retraction cannula
subcortical access sheath 6.2 cm
Minnetronix Neuro, Inc.
6.2cm
In Commercial Distribution

  • 00860003476819 ()

  • Length: 6.2 Centimeter
N-EXP1A-062

  • Neurosurgical retraction cannula
Subcortical access sheath 7.7cm
Minnetronix Neuro, Inc.
7.7cm
In Commercial Distribution

  • 00860003476802 ()

  • Length: 7.7 Centimeter
N-EXP1A-077

  • Neurosurgical retraction cannula
Lexie Lumen Duo Metalic Black - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Metalic Black
In Commercial Distribution

  • 00860003469880 ()
LLO00002MB

  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen Duo Bronze - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Bronze
In Commercial Distribution

  • 00860003469866 ()
LLO00002BR

  • Air-conduction hearing aid, receiver-in-canal
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