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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 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
Internal Expansion Tower
K2M, INC.
2112-22430
In Commercial Distribution

  • 10888857033559 ()

  • Height: 24 Millimeter
  • Length: 24 Millimeter
  • Width: 30 Millimeter
2112-22430

  • Vertebral body prosthesis
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
11mm H x 10mm W x 24mm L TLIF Sizing Trial
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587TT1110240 ()

  • Width: 24 Millimeter
  • Length: 24 Millimeter
  • Height: 11 Millimeter
TT111024

  • Spinal implant trial
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
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
Adherence Dual Cure Resin Cement Kit
SEPTODONT, INC
01C2000
In Commercial Distribution

  • 00303620000505 ()

  • Weight: 4 Gram


  • Dental composite resin
Natural Elegance Sealant
HENRY SCHEIN, INC.
1126407
In Commercial Distribution

  • 00304040007129 ()

  • Sealant Syringe x 4
  • Total Volume: 3 Milliliter
  • Weight: 1 Gram
  • Etchant Liquid
  • Needle Gauge: 22 Gauge
  • Syringe Tip x 6
1126407

  • Dental pit/fissure sealant
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