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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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LLIF IMPLANT TRIAL, MODULAR, STRAIGHT
HYHTE HOLDINGS, INC.
GZC01D10G
In Commercial Distribution

  • 00840085209758 ()

  • Width: 24 Millimeter
  • Height: 24 Millimeter
  • Angle: 30 degree
GZC01D10G

  • Spinal implant trial
LLIF IMPLANT TRIAL, MODULAR, ANGLED RIGHT
HYHTE HOLDINGS, INC.
GZC11D10F
In Commercial Distribution

  • 00840085214233 ()

  • Width: 24 Millimeter
  • Height: 24 Millimeter
  • Angle: 30 degree
GZC11D10F

  • Spinal implant trial
LLIF IMPLANT TRIAL, MODULAR, ANGLED LEFT
HYHTE HOLDINGS, INC.
GZC10D10G
In Commercial Distribution

  • 00840085211997 ()

  • Width: 24 Millimeter
  • Height: 24 Millimeter
  • Angle: 30 degree
GZC10D10G

  • Spinal implant trial
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
External Counter Pulsation Device
NORTH AMERICAN ECP INC.
NCP-2
In Commercial Distribution

  • 00868331000409 ()

  • Height: 29 Inch
  • Length: 80 Inch
  • Width: 35.25 Inch
  • Width: 30 Inch
  • Height: 66.5 Inch
  • Length: 18.5 Inch
No

  • External counterpulsation system, stationary
Celerity HP Indicator Tape
STERIS CORPORATION
PCC077
In Commercial Distribution

  • 10724995231504 ()
  • 00724995231507 ()

  • Length: 60 Yard
PCC077

  • Chemical/physical sterilization process indicator
The VERIFY VH202 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change. It can be changed in all V-PRO Low Temperature Sterilization Systems and Sterrad 100S, NX and 100NX Sterilizers.
STERIS CORPORATION
PCC070
Not in Commercial Distribution

  • 00724995002534 ()
  • 50724995002539 ()

  • Length: 60 Yard
PCC070

  • Sterilization packaging tape
VPS Impression Tray Material
DEN-MAT HOLDINGS, LLC
012381
In Commercial Distribution

  • 00359883006525 ()

  • Total Volume: 380 Milliliter
012381

  • Silicone dental impression material
VPS Impression Material
DEN-MAT HOLDINGS, LLC
013386
In Commercial Distribution

  • 00359883006006 ()

  • Total Volume: 380 Milliliter
013386

  • Silicone dental impression material
VPS Impression Material
DEN-MAT HOLDINGS, LLC
013381
In Commercial Distribution

  • 00359883005993 ()

  • Total Volume: 380 Milliliter
013381

  • Silicone dental impression material
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