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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Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-08
Not in Commercial Distribution

83-DILATOR-08

  • Nerve/vessel retractor
Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-05
Not in Commercial Distribution

83-DILATOR-05

  • Nerve/vessel retractor
Compressor
Pioneer Surgical Technology, Inc.
83-COMPRESSOR
Not in Commercial Distribution

  • 00846468002701 ()
83-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit
Instrument Case
Pioneer Surgical Technology, Inc.
83-CASE
Not in Commercial Distribution

  • 00846468002695 ()
83-CASE

  • General internal orthopaedic fixation system implantation kit
Barrel Plate Inserter
Pioneer Surgical Technology, Inc.
83-B-INSERTER
Not in Commercial Distribution

83-B-INSERTER

  • General internal orthopaedic fixation system implantation kit
BACFUSE,INLINE TORQUE LIMITING HANDLE,UL
Pioneer Surgical Technology, Inc.
725-016
Not in Commercial Distribution

  • 00846468000516 ()

  • 30in-lbs (Torque)
725-016

  • General internal orthopaedic fixation system implantation kit
The LifeWarmer Quantum Thermal Infusion Set (TIS) is the revolutionary IV tubing set that allows for safe, rapid warming of IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard IV infusion tubing, the familiar configuration allows for ease of use. The sophisticated intelligence and proprietary warming technology are integrated into the tubing system for simplicity and to reduce additional equipment and procedural steps. Roughly the same size and weight as standard IV tubing, there is almost no additional equipment burden. The Quantum IV administration tubing is double-extruded to yield a configuration that has both an inner tubing layer and an outer tubing layer. A conductive heating element is between the two layers but does not come in contact with the fluid path or disrupt the laminar flow. The outer tubing layer acts as an insulator while the inner tubing layer transfers the heat from the heating element to the fluid path. Thermistors located in the tubing continually measure temperature and provide that input to the Quantum Controller. The monitoring and independent application of energy (heat) along the fluid path allows the Quantum to respond to varying temperature inputs from the fluid source to near the point of patient entry to ensure fluid temperature is the right temperature at delivery. The Quantum Life Warmer, fully charged, is able to warm and maintain up to approximately 1700 mL of 20C IV solution to a set point of 100.4F (38 +/- 2C) at a flow rate of 200 mL/min. Effective warming flow rates range from 2 to 200 mL/minute depending on input fluid temperature and ambient conditions.
NORTH AMERICAN RESCUE, LLC
63-5903
In Commercial Distribution

  • 00868058000461 ()
  • 00868058000409 ()
35-0004

  • Conduction blood/fluid warmer
Driver
Pioneer Surgical Technology, Inc.
83-DRIVER
Not in Commercial Distribution

  • 00846468047801 ()
83-DRIVER

  • Orthopaedic counter-torque/rod-pushing instrument
5mm Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-05
Not in Commercial Distribution

  • 00846468047788 ()
83-DILATOR-05

  • Nerve/vessel retractor
Barrel Plate Inserter
Pioneer Surgical Technology, Inc.
83-B-INSERTER
Not in Commercial Distribution

  • 00846468047757 ()
83-B-INSERTER

  • General internal orthopaedic fixation system implantation kit
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